| Date | Title | Description |
| 22.05.2025 | Adapting Alzheimer's Trials to a New Therapeutic Landscape: Early Detection and Operational Complexities, Upcoming Webinar Hosted by Xtalks | www.premier-research.com
In this free webinar, gain insights into the evolving Alzheimer's Disease treatment and regulatory landscape. Attendees will learn about diagnostic criteria and early detection methods. The featured speakers will sh... |
| 30.04.2025 | Beyond the Hype: Innovating Obesity Treatments for Real-World Impact, Upcoming Webinar Hosted by Xtalks | www.premier-research.com
In this free webinar, gain insight into obesity drug development and the evolving treatment landscape. Attendees will learn about gaps in current approved treatments, emerging mechanisms of action, and ways to overc... |
| 23.04.2025 | Breaking Free from SDR and SDV: The Case for Centralized Monitoring, Upcoming Webinar Hosted by Xtalks | www.premier-research.com
In this free webinar, learn about the benefits of executing a centralized monitoring strategy from a global clinical operations expert. Attendees will gain insights into source data review (SDR) and source data veri... |
| 05.02.2025 | 3A Rare Look into New Guidances: The Future State of Orphan Drug Development, Upcoming Webinar Hosted by Xtalks | www.premier-research.com
In this free webinar, learn about the rare disease landscape, including 2024 approval trends. Attendees will gain insights into the key regulatory guidances published within the past year and their impact on rare di... |
| 10.01.2025 | The New Era of CDx in Oncology: Adapting Clinical Research Strategy to Evolving Regulations, Upcoming Webinar Hosted by Xtalks | www.premier-research.com
In this free webinar, learn about the regulatory landscape for companion diagnostics (CDx), including recent changes to the regulation of laboratory-developed tests (LDTs). The featured speakers will discuss the imp... |
| 23.10.2024 | Shifting Perceptions in Psychedelics: Challenges and Progress in Drug Development, Upcoming Webinar Hosted by Xtalks | www.premier-research.com
In this webinar, gain insights from the recent advisory committee (ADCOM) meeting and the US Food and Drug Administration (FDA) action letter for Lykos' new drug application (NDA) for using 3,4-methylenedioxymethamp... |
| 02.10.2024 | Embracing a Culture of Quality: Establishing and Maintaining Effective CRO Oversight, Upcoming Webinar Hosted by Xtalks | www.premier-research.com
In this webinar, learn about the key components to monitor in contract research organization (CRO) and vendor oversight. Attendees will review ISO and ICH guidelines, including expectations for ICH E6(R3). The featu... |
| 22.08.2024 | Next-Generation CAR-T Therapies: Optimizing Opportunities and Operationalizing Patient-Centric Oncology Clinical Trials, Upcoming Webinar Hosted by Xtalks | www.premier-research.com
In this webinar, learn about recent advancements in chimeric antigen receptor (CAR)-T cell therapy design and application. Attendees will discover the impact of next-generation CAR-T therapies on clinical trial oper... |
| 12.06.2024 | Asking the Right Questions: How the Patient Perspective Impacts the Success of Rare Disease Studies, Upcoming Webinar Hosted by Xtalks | www.premier-research.com
In this webinar, learn about the unique challenges of patient engagement in rare disease clinical research. Attendees will gain insights into building relationships with patients early in development and approaches ... |
| 01.05.2024 | The Power of Clinical Data: Why Strategic PMCF Studies Matter, Upcoming Webinar Hosted by Xtalks | www.premier-research.com
In this webinar, learn about the regulatory framework for post-market clinical follow-up (PMCF). Attendees will gain insights into planning a PMCF strategy and designing a PMCF investigation. The featured speakers w... |
| 24.04.2024 | Optimizing Site Selection to Increase the Efficiency and Quality of Clinical Trials, Upcoming Webinar Hosted by Xtalks | www.premier-research.com
In this webinar, learn about the challenges to efficient clinical trial site selection and tips for optimizing site feasibility assessments. The featured speaker will share strategies for decreasing cycle times and ... |
| 20.03.2024 | Going Global: Bringing Drugs for Depression to Market in the US and EU, Upcoming Webinar Hosted by Xtalks | www.premier-research.com
In this free webinar, gain insights into how to bring drugs for depression to market in the US and EU. Attendees will learn about the potential impact of the draft European Medicines Agency (EMA) guidance on develop... |
| 18.03.2024 | IVD Survival Guide: Navigating Uncertainty in the US and European IVD Regulatory Landscape, Upcoming Webinar Hosted by Xtalks | www.premier-research.com
In this free webinar, gain insights into how regulatory guidance can help in vitro diagnostic (IVD) developers proactively navigate uncertainty and mitigate potential financial, compliance and operational risks. Att... |
| 06.07.2023 | Risk Detection in Neuroscience Trials: Are You Missing Early Warning Signs? Upcoming Webinar Hosted by Xtalks | Xtalks Life Science Webinars The webinar aims to shed light on the key factors contributing to the failure of neuroscience trials and to offer effective risk detection strategies.
TORONTO, Ontario (PRWEB) July 06, 2023
A new educational web... |
| 10.05.2023 | In Vitro Diagnostics for Early Cancer Detection: The Evolution and Promise of Liquid Biopsy Technology, Upcoming Webinar Hosted by Xtalks | In this webinar, the featured speakers will explore the technique’s growing importance in early cancer detection and address common questions about its use.
TORONTO (PRWEB) May 10, 2023
As liquid biopsies become more commonplace, gaining wi... |
| 02.03.2023 | CAR T-Cell Therapies: Extending Hope with Broadened Access, Upcoming Webinar Hosted by Xtalks | There is significant potential to expand the applications of — and broaden access to — CAR T-cell therapies to address unmet needs.
TORONTO (PRWEB) March 02, 2023
CAR T-cell therapies have transformed the therapeutic landscape for hematolog... |
| 01.09.2022 | Accelerate Product Approval Using In Silico Modeling & Simulation, Upcoming Webinar Hosted by Xtalks | The FDA encourages the use of in silico clinical trials in which a drug or device is tested against a cohort of virtual patients, therefore providing an empirical basis for appropriate comparative assessment.
TORONTO (PRWEB) September 01, 2... |
| 29.11.2021 | Addressing the Challenges and Opportunities in Gynecologic Cancer Research, Upcoming Webinar Hosted by Xtalks | The recent introduction of novel medicines — targeted therapies in particular — has led to improvements in patient care and uncovered new research opportunities, creating a competitive research environment.
TORONTO (PRWEB) November 29, 2021... |
| 07.10.2021 | Empowering Oncology Patients to Maximize Study Outcomes: Strategies and Considerations for Sponsors, Upcoming Webinar Hosted by Xtalks | A patient who isn’t adequately engaged will not complete follow-up long term — if they even stay throughout the treatment portion of the study.
TORONTO (PRWEB) October 07, 2021
Patient recruitment comprises one of the most significant initi... |
| 06.08.2021 | Senate Dems call to add Medicare drug price negotiations to reconciliation bill; Certara signs $310M buyout of software company | Don’t forget to include drug pricing reforms in the upcoming $3.5 trillion reconciliation bill, Sens. Amy Klobuchar (D-MN), Dianne Feinstein (D-CA) and 10 of their colleagues urged Senate leaders Chuck Schumer, Bernie Sand... |
| 06.08.2021 | Court decision pushes FDA to make historical shift and regulate borderline drug/device products as devices | Moderna’s little business deal with Autolus earlier this week looks like a predinner snack ahead of the main course to come.
During his Q2 call with analysts on Thursday, Moderna CEO Stéphane Bancel got more than a few eyebrows to raise wit... |
| 06.08.2021 | Vertex taps longtime commercial lead to fill two-year COO vacancy; Nancy Thornberry set for different role at Kallyope with an old friend from Merck waiting in the wings | For the first time in two years, Vertex has a COO.
Stuart Arbuckle
The cystic fibrosis drugmaker announced Wednesday that Stuart Arbuckle, who has led the company’s commercial efforts since 2012, has been appointed to r... |
| 06.08.2021 | Court decision pushes FDA to make historical shift and regulate borderline drug/device products as devices | EQRx, a would-be drug pricing disruptor that has emerged as an investor darling, has everything but an approval to show in its fight against financial toxicity in biopharma. With the homestretch closing in, the team is now ready for its clo... |
| 06.08.2021 | FDA orders clinical hold on Aprea's p53 reactivator as struggling biotech pledges to address safety concerns | Little Aprea Therapeutics just tripped yet again on its rocky path to develop a drug that can reactivate the mutant tumor suppressor protein p53.
The Boston-based biotech said the FDA has placed a partial clinical hold on i... |
| 06.08.2021 | Court decision pushes FDA to make historical shift and regulate borderline drug/device products as devices | Normally, new generic drug competition can enter the market for one or some of the approved indications of its brand-name counterpart’s label. That new generic drug’s label, known as a “skinny” label because it doesn’t include all of the re... |
| 06.08.2021 | Chinese startup with Merck vet at the helm acquires rights to Oyster Point's eye disease nasal spray | With the Chinese drug market starting to bear fruit, Western drugmakers have looked to wiggle their way in, often leaning on local partners to do the grunt work on the ground. With so many Chinese companies playing the willi... |
| 06.08.2021 | Court decision pushes FDA to make historical shift and regulate borderline drug/device products as devices | Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up... |
| 06.08.2021 | Court decision pushes FDA to make historical shift and regulate borderline drug/device products as devices | Rack up another delay for Novavax $NVAX on the crucial EUA front.
The biotech’s Q2 review dropped after the market close on Thursday, and with it came the news that their request for an emergency use approval of their Covid-19 vaccine at th... |
| 06.08.2021 | Sanofi wins approval for Lumizyme successor, although uptake remains a mystery | It’s not yet clear how many patients will actually take it, but for the first time in 15 years, there is a new treatment available for the rare and deadly genetic condition Pompe disease.
The FDA approved avalglucosidase al... |
| 06.08.2021 | Court decision pushes FDA to make historical shift and regulate borderline drug/device products as devices | Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.
The biotech industry was set to end this week with another two major public debuts. The first company, Tillman Gerngross’ antib... |
| 05.08.2021 | Moderna's Covid-19 vaccine sales to trail Pfizer's total significantly in 2021 and 2022 | Pfizer’s and Moderna’s mRNA vaccines to prevent Covid-19 are often considered equals in many respects. Both have shown strong protection from the virus, with limited side effects or safety concerns among the hundreds of millions who have no... |
| 05.08.2021 | A small vaccine developer favored by the UK government in Covid-19 touts a PhIII first in chikungunya | Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.
It now has ... |
| 05.08.2021 | Emerging from stealth mode, Aardvark rounds up enough cash to put its lead drug through Prader-Willi PhII | When Aardvark Therapeutics CEO Tien Lee started his work on the biotech’s lead candidate, appetite suppression was the goal for the small molecule. Soon after, his team started to see added benefits with lower blood glucos... |
| 05.08.2021 | Celularity teams up with Australian biotech to develop CAR T-cell therapy; Former Kinnate CEO Stephen Kaldor reels in $50M for new biotech | Imugene and Celularity have announced a partnership to develop a solid tumor treatment, the two companies announced Wednesday.
The collaboration will explore the use of Imugene’s CF33-CD19, an oncolytic virus, and Ce... |
| 05.08.2021 | Libtayo, chemo combo clears lung cancer trial two years early. But can it compete with Keytruda? | With the sixth checkpoint inhibitor on the US market, Regeneron and Sanofi sought to create their own market for Libtayo by going after indications other drugmakers hadn’t. That all changed in February when Libtayo scored... |
| 05.08.2021 | UK re-investigates Pfizer's eye-popping price gouging on an epilepsy drug | When a drugmaker raises the price of a drug in the US by more than 2,000% overnight, and without any particular reason for that increase, nothing typically happens to the company. No fines, no court orders, just business a... |
| 05.08.2021 | Merck's Keytruda takes home adjuvant win in melanoma, escalating early-line fight with Bristol Myers | With immune checkpoint inhibitors quickly emerging as standard of care across a broad range of advanced cancers, the biggest drugmakers in the race are making a hard push into earlier lines of therapy to gain an edge. The bi... |
| 04.08.2021 | Ardelyx chops a third of its staff after stock-crushing failure in chronic kidney disease | A couple of weeks after the FDA turned down Ardelyx’s chronic kidney disease candidate, shocking analysts and CEO Mike Raab, the company is axing 33% of its employees to deal with the loss.
Ardelyx shared in an SEC filing ... |
| 04.08.2021 | Science pioneer, pharma research chief, global health advocate and biotech entrepreneur Tadataka ‘Tachi’ Yamada has died | Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going... |
| 04.08.2021 | Zymergen's sudden implosion shocked biotech. A lingering loan could make things even worse | As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising e... |
| 04.08.2021 | Samantha Du's Zai Lab inks surprising research collab with Schrödinger for DNA damage drug | Headed by Samantha Du, Chinese oncology specialist Zai Lab has made no qualms about its aggressive in-licensing strategy to drive Western drugs into regional markets. That strategy has been profitable so far, but that... |
| 04.08.2021 | Amgen adds new NC plant to the list as part of $1B manufacturing expansion plans stateside | What can $1 billion buy? If you’re Amgen, it’s good for two manufacturing facilities in the US.
The California-based drug giant will invest close to $550 million in a drug substance plant in Holly Springs, NC, adding itsel... |
| 04.08.2021 | Amgen may see $3B+ in additional taxes; EQRx, AbCellera ink antibody development deal | Alongside the release of its Q2 results late Tuesday, Amgen also signaled that it’s defending what could be a sizeable chunk of cash that it owes the IRS.
Last month, the company said it filed a petition in the US Tax Court to... |
| 04.08.2021 | Science pioneer, pharma research chief, global health advocate and biotech entrepreneur Tadataka ‘Tachi’ Yamada has died | The government investigation into how the FDA approved Aduhelm appears to point well beyond the agency’s ties with Biogen in the leadup to its approval of their controversial Alzheimer’s drug Aduhelm.
The HHS Office of Inspector General pos... |
| 04.08.2021 | Pfizer puts the pressure on Eli Lilly's JAK inhibitor Olumiant with new data in alopecia areata | Amgen did a bit of a balancing act for its column of Phase I oncology programs during the latest quarterly update, as it disclosed that it’s resumed dosing for pavurutamab (AMG 710) but halted enrollment to a trial for AMG 427. Both were Bi... |
| 04.08.2021 | SoftBank claims $5B stake in Roche amid grand plans to invest in biotech — reports | SoftBank has made a somewhat surprising choice in its bid to pour billions into biotech and healthcare.
The Japanese behemoth has quietly acquired a $5 billion stake in Roche, making it one of the Swiss pharma giant’s large... |
| 04.08.2021 | Pfizer puts the pressure on Eli Lilly's JAK inhibitor Olumiant with new data in alopecia areata | As Eli Lilly looks to secure a win for its blockbuster Olumiant in alopecia areata, going where no JAK inhibitor has gone before, Pfizer is coming up from behind with Phase IIb/III results suggesting its own candidate can ... |
| 04.08.2021 | Pfizer puts the pressure on Eli Lilly's JAK inhibitor Olumiant with new data in alopecia areata | Jeff Bluestone had some big goals in mind when he decided to make a switch from a decades-long career in academia and non-profit research to a biotech startup CEO. And now — 18 months after the $40 million launch party — he has a whole lot ... |
| 04.08.2021 | Science pioneer, pharma research chief, global health advocate and biotech entrepreneur Tadataka ‘Tachi’ Yamada has died | It’s been five years since the FDA decided to approve Sarepta’s Duchenne muscular dystrophy drug Exondys 51 on a sliver of biological evidence, and still there are little data to show the drug can actually slow patients’ decline.
That pauci... |
| 03.08.2021 | Going so soon? Scholar Rock CEO makes swift exit, leaving Nagesh Mahanthappa back at the helm | Tony Kingsley
Just over a year after taking the helm at Cambridge, MA-based Scholar Rock — and just as the company prepares to send its lead spinal muscular atrophy candidate to Phase III — CEO Tony Kingsley is already on hi... |
| 03.08.2021 | Sage drops a pair of late-stage tests for Biogen-partnered depression drug, raising the stakes on a final trial | BeiGene has made its presence in the US known with the FDA approval of its oncology treatment two years ago, and its five offices across the country. Tuesday, the company announced that it will add a sixth location, this time an R&D and... |
| 03.08.2021 | Roche's PD-L1 franchise player nabs priority review; One of world's first psychedelics research institutes opens in Australia | The FDA has just put Genentech’s latest shot at adding blockbuster sales for Tecentriq on the regulator’s inside track.
Roche said Tuesday that the agency has provided priority review status for a supplemental NDA to get ... |
| 03.08.2021 | J&J, GV back a new single-cell approach for tackling inflammatory diseases and hacking the tumor microenvironment | Most biotechs trying to tackle inflammatory disorders like IBD or attempting to boost the potency of immunotherapies for cancer have focused, logically, on targeting, blocking or redirecting immune cells.
J&J, ... |
| 03.08.2021 | After struggling with its sole drug for years, Marinus rides positive data to a commercialization deal in Europe | After a series of painful setbacks, Marinus had a rebirth of sorts last year when it offered a positive late-stage preview of its sole drug, ganaxolone, in a genetic disorder that causes early-onset epilepsy. Now, CEO Sco... |
| 03.08.2021 | Sage drops a pair of late-stage tests for Biogen-partnered depression drug, raising the stakes on a final trial | When Sage Therapeutics’ star experimental depression drug, zuranolone, failed the crucial MOUNTAIN study, the biotech slammed the brakes on two other pivotal trials in order to rethink their design.
Now that a second Pha... |
| 03.08.2021 | Rare disease drugmakers to Congress: Don't gut the accelerated approval pathway | The controversy over the FDA’s accelerated approval pathway is heating up.
Last week, the FDA’s top oncology official Rick Pazdur said the pathway is “under attack,” largely due to the agency’s recent accelerated ap... |
| 03.08.2021 | Roche's PD-L1 franchise player nabs priority review; One of world's first psychedelics research institutes opens in Australia | Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.
A year after paying Translate Bio $TBIO a whopping $425 million in an upfront and equity payment to help guide the... |
| 03.08.2021 | Opinion: Pricing info with new drug approvals: Time for transparency | For years Congress has raised concerns with the way some drugmakers pay to delay generic versions of their branded blockbusters, as well as other patent and evergreening techniques to add to their sales of older products.
The... |
| 02.08.2021 | FTC pulls remaining case against AbbVie; New EU clinical trials system coming in 2022; Abingworth bets big on CymaBay | With AstraZeneca’s second quarter earnings call Thursday morning came updated sales numbers for its Covid-19 vaccine — and compared to the big mRNA players, the numbers pale in comparison.
The British-Swedish drugmaker reported its Covid-19... |
| 02.08.2021 | FTC pulls remaining case against AbbVie; New EU clinical trials system coming in 2022; Abingworth bets big on CymaBay | This morning we got a better look at the numbers Tillman Gerngross has in mind for his pandemic play at Adagio Therapeutics. And not surprisingly, they are big.
Gerngross has had plenty of experience judging value in biotech. And at a time ... |
| 02.08.2021 | Ipsen continues its shopping spree with a $1B-plus deal for Exicure's next-gen oligonucleotides | Ipsen has been on a deal-making spree the last few weeks, shelling out more than a billion dollars in two separate deals to work on a mid-stage levodopa-induced dyskinesia (LID) candidate and a preclinical BAX inhibitor in s... |
| 02.08.2021 | Tibsovo clears another hurdle for Servier, but can it make Agios' old drug profitable? | When European regulators saw the data Agios used to win US approval for their AML drug Tibsovo, they sent the more than decade-old biotech back to the drawing board. A single, single-armed trial was not going to cut it.
On Mon... |
| 02.08.2021 | FTC pulls remaining case against AbbVie; New EU clinical trials system coming in 2022; Abingworth bets big on CymaBay | Hot off its earnings report that showed a slight dip in sales connected to HIV but a steady increase in revenue from its Covid-19 treatment, Gilead is headed to North Carolina’s Research Triangle.
Gilead will open office space in Raleigh la... |
| 02.08.2021 | Moderna takes on a low-risk pact with CAR-T player Autolus for mRNA-based cancer drugs | Moderna’s Covid-19 vaccine has transformed the once-backwater biotech into one of the most highly valued drugmakers in the world in the span of a year. But what does the future hold for Moderna’s star turn? A small-scale disc... |
| 02.08.2021 | Drug supplier Abcam brings a longtime collaborator in house as part of $340M buyout pact | BeiGene blazed the trail for a growing wave of Chinese oncology drugs breaking through in the US with an initial approval for BTK inhibitor Brukinsa back in 2019, and now the US/Chinese drugmaker has set the stage for its lead drug’s next b... |
| 02.08.2021 | Bristol Myers pulls lymphoma indication for Istodax after confirmatory trial falls flat | Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now... |
| 02.08.2021 | Drug supplier Abcam brings a longtime collaborator in house as part of $340M buyout pact | BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.
Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboa... |
| 02.08.2021 | Covid-19 roundup: Regeneron's mAB gets expanded EUA; mRNA drugmakers spike price of vaccines in EU supply deal | The FDA has expanded the authorization for Regeneron’s Covid-19 treatment Regen-Cov in an announcement Friday.
The authorization now covers post-exposure prophylaxis for those exposed to an infected person or who ar... |
| 02.08.2021 | FTC pulls remaining case against AbbVie; New EU clinical trials system coming in 2022; Abingworth bets big on CymaBay | Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up... |
| 02.08.2021 | FTC pulls remaining case against AbbVie; New EU clinical trials system coming in 2022; Abingworth bets big on CymaBay | The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.
The punt by SCOTUS means that while the Illinois pharma company illeg... |
| 02.08.2021 | Drug supplier Abcam brings a longtime collaborator in house as part of $340M buyout pact | What made GSK’s Hal Barron spend $700 million cash to get in on a pair of antibodies for neurodegeneration?
Alector flashed part of the answer Thursday, detailing early data from their lead drug in a genetic and rapidly progressing form of ... |
| 02.08.2021 | FTC pulls remaining case against AbbVie; New EU clinical trials system coming in 2022; Abingworth bets big on CymaBay | Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.
Roivant... |
| 02.08.2021 | FTC pulls remaining case against AbbVie; New EU clinical trials system coming in 2022; Abingworth bets big on CymaBay | Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.
Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since Glaxo... |
| 02.08.2021 | With clinical trials lined up for Zentalis drugs, China's Zentera sets its sights on more dealmaking and an IPO | T-knife Therapeutics launched last August on a mission to isolate T cell receptors not from human donors, but from mice. Now, with a new CEO and a candidate bound for the clinic, the Versant-backed company is reloading with a fresh $110 mil... |
| 02.08.2021 | FTC pulls remaining case against AbbVie; New EU clinical trials system coming in 2022; Abingworth bets big on CymaBay | Contract researcher Charles River Laboratories has taken advantage of the hot manufacturing market, extending its CDMO arm through a flurry of mergers and acquisitions. In a change of pace, it will add on to its already existing Ballina, Ir... |
| 30.07.2021 | Cavazzoni in the hot seat: House committee grills CDER director on neuro drugs | CDER Director Patrizia Cavazzoni may be new to her position, but the House Energy & Commerce Committee isn’t using kid gloves when grilling her on the FDA’s work on neurodegenerative disease treatments.
Representa... |
| 30.07.2021 | Roche China CEO preps for a move to Merck KGaA while US Merck adds to C-suite; Succession plan finalized for EVPs retiring from Sanofi | Hong Chow
→ Beginning Oct. 1, Roche China CEO Hong Chow will be head of China & international for Merck KGaA’s healthcare business, a position that also encompasses Japan, Europe, Latin America, Asia-Pacific, the M... |
| 30.07.2021 | Six more biotechs price public debuts just before the start of the weekend | Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.
Another six biotechs priced IPOs on Thursday and Friday, joining this week’s big rush to Wall Street. Biotech ... |
| 30.07.2021 | Covid-19 roundup: Brazil backs out of Sputnik V vaccine deal; White House implements new mask, vaccine mandates | In March, Brazil’s government signed a contract with Russia for 10 million doses of the Sputnik V vaccine. Now, the country is backing out of that agreement with its health minister citing a lapsed registration deadline as... |
| 30.07.2021 | Biogen launches Phase IV trial to see just how well Aduhelm works in the real world | It could be years before Biogen wraps up its confirmatory trial for its controversial new Alzheimer’s drug Aduhelm (up to nine years, to be precise). But in the meantime, the company is launching a real-world, Phase IV study... |
| 30.07.2021 | Top Gilead cancer researcher jumps to a startup as Dan Chen exits; Ardelyx gets that CRL we've been waiting for | Chris Takimoto
Chris Takimoto, the former CMO at Forty Seven who completed a stint as SVP of oncology R&D at Gilead after the buyout, is moving on. He’s been given the CMO spot at IGM Biosciences.
Takimoto is taking t... |
| 30.07.2021 | Takeda and Frazier team up again to launch a spinout — this time focused on a late-stage vaccine | Takeda has plucked a late-stage vaccine from the pipeline and handed it to a spinout company — once again turning to some colleagues at Frazier Healthcare Partners to make the deal work.
The pharma giant is spinning out its no... |
| 29.07.2021 | Flush with cash, Rakuten billionaire Mickey Mikitani looks to take his photoimmunotherapy platform global | E-tailer billionaire Mickey Mikitani has backed Aspyrian Therapeutics’ photoimmunotherapy tech from the beginning, starting as a participant in the company’s $40 million Series A round and later taking the helm a... |
| 29.07.2021 | As leading synbio players bask in spotlight, US/China startup lands $100M to find its own niche | Tim Lu’s MIT lab is known for pushing the boundaries of biotech. Whether it’s Engine Biosciences’ AI platform or Senti Bio’s genetic circuits, it’s all about creating new therapies that can “outsmart” complex diseases throug... |
| 29.07.2021 | Could a fourth lead drug finally bring Infinity an approval? | Maybe fourth time’s the charm?
Infinity Pharmaceuticals, the thrice-failed oncology biotech, announced updated data Tuesday from its new lead drug in a pair of cancers, showing that bladder cancer patients who took its m... |
| 29.07.2021 | Covid-19 roundup: Eli Lilly's RA drug gets solo OK from FDA; Emergent gets greenlight to resume manufacturing at Bayview site | The FDA late Wednesday extended the EUA for Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib) to be used as a solo treatment for Covid-19 in hospitalized adults and pediatric patients who need supplemental ox... |
| 29.07.2021 | Merck and Pfizer back a Michigan startup's mission to advance tumor profiling | Dan Rhodes was leading cancer sequencing at Thermo Fisher Scientific when he noticed that, despite the rush of pharma companies developing targeted therapies, most patients weren’t getting the right testing — and the... |
| 29.07.2021 | Three more companies price IPOs, bringing this year's raise up to $11.78B | Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.
The biotech IPO rush continues, as three more companies — Nuvalent, Icosavax and Rallybio — priced their pub... |
| 29.07.2021 | Royalty Pharma competitor stirs the pot with plans for $750M IPO | Ostensibly aiming to piggyback off the success of Royalty Pharma and CEO Pablo Legorreta’s IPO in June 2020, another royalty-gobbling company is nearly set to do the Nasdaq shuffle.
Pablo Legorreta
Healthcare Royal... |
| 29.07.2021 | AstraZeneca and Amgen quietly admit tezepelumab setback as the Dupixent challenger heads to FDA | AstraZeneca and Amgen have blockbuster ambitions for their tezepelumab antibody, aiming to challenge the Regeneron and Sanofi giant Dupixent in asthma and related respiratory maladies. But as part of its second quar... |
| 29.07.2021 | Roche nabs priority review for Eylea competitor; Italy's Angelini eyes CNS, rare disease startups with $35M Lumira fund | The teams at Roche and Genentech are off and running at the FDA, with regulators accepting a quick pitch for what would be the first bispecific antibody designed for the eye.
Roche announced late Wednesday that its applica... |
| 28.04.2021 | Market Application and Life-Cycle Management: The Road to Commercial Success, Upcoming Webinar Hosted by Xtalks | Approval in the United States and European Union paves the way for a drug’s acceptance in many, but not all, other parts of the world — so which additional countries should you consider incorporating in your clinical trial strategy?
TORONTO... |
| 05.04.2021 | Pursuing Parkinson’s Disease Gene Therapies: Strategies & Operational Requirements, Upcoming Webinar Hosted by Xtalks | ...these studies face unique challenges due to their patient population and the complex regulatory considerations for these advanced therapies.
TORONTO (PRWEB) April 05, 2021
While treatment of Parkinson’s disease (PD) has traditionally bee... |
| 17.03.2021 | Considerations to Improve Patient Outcomes in Early Drug Development, Upcoming Webinar Hosted by Xtalks | A comprehensive examination of the roles played by all participants has the potential to produce faster and more concrete results, leading to improved patient outcomes.
TORONTO (PRWEB) March 17, 2021
Every drug development program must begi... |
| 11.03.2021 | Pathways to Expedited Drug Development in the U.S. and Europe, Upcoming Webinar Hosted by Xtalks | This webinar will show you where to start and how to envision the end, describe the U.S. and European pathways for accelerating development and equip you to engage with regulators effectively.
TORONTO (PRWEB) March 11, 2021
Preparing for ex... |
| 18.02.2021 | The Regulatory Landscape of Software as a Medical Device, Upcoming Webinar Hosted by Xtalks | The challenge is when a software is designated as SaMD, a string of regulatory requirements come into play, creating a maze of potential pathways and product development implications.
TORONTO (PRWEB) February 18, 2021
So much of the medical... |
| 08.02.2021 | Alternative Designs to the Traditional 3+3 Design in Phase 1 Dose Escalation Studies, Upcoming Webinar Hosted by Xtalks | The risk of selecting a sub-therapeutic dose as the RP2D is a key limitation of the traditional 3+3 dose-escalation design in Phase 1.
TORONTO (PRWEB) February 08, 2021
Phase 1 clinical trials aim to determine the maximum tolerated dose (MT... |
| 18.10.2016 | Metalmark invests in Premier Research | RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–Premier Research, a leading middle-market contract research organization that provides comprehensive clinical development, analytic, and support services to pharmaceutical, biotech, and medical d... |
