| 02.18.22 | GSK’s maternal RSV va x in the penalty box, handing advan tage to Pfizer; BioMarin’s gene the rapy on hold for ‘several quarters’

Laden...

2 jaren geleden

Html
Tekst

Whitepaper: Early engagement & regulatory considerations for emerging biotechs

Despite robust funding and government initiatives for the development of orphan drugs and personalised medicines, small and emerging biotechs are typically very lean on resources, lacking the infrastructure required to bring their innovation to the market. Gain insight into the common questions small and emerging biotech companies face, and the importance of early engagement and regulatory affairs when developing an asset and considering a drug development partner. Learn more.

Editor’s Note: Fierce Biotech will not publish on Monday in observance of Presidents Day, but we'll be back in your inbox on Tuesday, Feb. 22. Have a great weekend!

Today's Rundown

GSK, in close race with Pfizer, slams brakes on phase 3 maternal RSV vaccine program over safety signal FDA grounds BioMarin gene therapy trial for months with demand for tumor risk data 'Early stage': Majority of biotechs don't disclose ESG practices, but most plan to in near term Sponsored: A New Way to Access Scientific Papers? Ligand to spin off J&J-partnered antibody unit with $70M in funding Ribon taps former Novartis VP, Flagship partner Raman as CEO Bayer hikes Nubeqa's peak sales to more than €3B on prostate cancer data, teeing up new 3-way battle against Pfizer-Astellas, J&J Agios' first-in-class PK activator Pyrukynd scores FDA approval to treat rare blood disorder FDA hands down Class I rating to Vyaire Medical's ventilator recall FTC deadlocked on whether to study PBM contracting practices such as DIR fees Curebase adds real-world data, AI experts to board in decentralized trial push Is there a case for more medical emoji? Study looks at how clinicians use them on the job Fierce Pharma Asia—Lilly, Innovent's I-O implications; Novartis' India job cuts; Moderna's Asia expansion Chutes & Ladders—Califf returns to FDA after narrow Senate confirmation

Featured Story

GSK, in close race with Pfizer, slams brakes on phase 3 maternal RSV vaccine program over safety signal

By Nick Paul Taylor

GlaxoSmithKline has slammed the brakes on its pivotal maternal respiratory syncytial virus (RSV) vaccine program after a safety assessment, potentially handing an advantage to Pfizer in a close race to market.

Sterile filling for complex, high-value APIs and biologics

Maximize your sterile fill batch yield up to 98% with Eurofins BioPharma Product Testing’s state-of-the-art instrumentation designed for small volume runs. With flexible scheduling and streamlined batch records, we can help you ensure fast delivery to the patient. Learn more.

FDA grounds BioMarin gene therapy trial for months with demand for tumor risk data

By Nick Paul Taylor

BioMarin Pharmaceutical faces a long clinical hold on its phenylketonuria (PKU) gene therapy trial. After stopping the trial over tumors in mice, the FDA has asked BioMarin to run additional nonclinical studies that are expected to take “several quarters” to assess the risk of BMN 307.

'Early stage': Majority of biotechs don't disclose ESG practices, but most plan to in near term

By Kyle LaHucik

The biotech industry has not caught the ESG bug that has swept across C-suites in recent years as part of the broad push for corporate social responsibility, according to a survey and review from life sciences law firm Fenwick.

Ligand Pharmaceuticals will spin off its Johnson & Johnson-partnered antibody platform business OmniAb and capitalize the company with $70 million.

Ribon taps former Novartis VP, Flagship partner Raman as CEO

By Max Bayer

Cellular stress-focused biotech Ribon Therapeutics has hired former Novartis VP and Flagship Pioneering Senior Partner Prakash Raman, Ph.D., as its new CEO.

Bayer hikes Nubeqa's peak sales to more than €3B on prostate cancer data, teeing up new 3-way battle against Pfizer-Astellas, J&J

By Angus Liu

Bayer has spelled out an even more bullish estimate for Nubeqa's blockbuster potential, thanks to a trial win in a new prostate cancer frontier for the androgen receptor inhibitor. But the German drugmaker still faces an uphill fight against two formidable incumbent players.

Agios' first-in-class PK activator Pyrukynd scores FDA approval to treat rare blood disorder

By Eric Sagonowsky

More than a decade after its founding, Agios Pharmaceuticals has its first FDA green light. With the approval for Pyrukynd to treat hemolytic anemia in adults with pyruvate kinase deficiency, the company is off and running in the commercial arena.

FDA hands down Class I rating to Vyaire Medical's ventilator recall

By Andrea Park

So far, no deaths have been reported in connection with the software flaw, but the FDA has received 18 complaints and reports of seven injuries linked to the issue.

FTC deadlocked on whether to study PBM contracting practices such as DIR fees

By Robert King

The FTC deadlocked on whether to initiate a study into contracting practices of the PBM industry, despite fervent lobbying from pharmacists.

Curebase adds real-world data, AI experts to board in decentralized trial push

By Gareth Macdonald

Curebase has added real-world data and artificial intelligence experts to its advisory board in a bid to capture a greater share of the decentralized trials market.

Is there a case for more medical emoji? Study looks at how clinicians use them on the job

By Anastassia Gliadkovskaya

Communications software company PerfectServe wondered whether it could identify evidence of burnout or frustration among clinicians expressed through emoji. But the company discovered just the opposite – emoji were overwhelmingly used to convey politeness and positive intent. Some researchers and physicians have made a case for a comprehensive set of medical emoji.

Fierce Pharma Asia—Lilly, Innovent's I-O implications; Novartis' India job cuts; Moderna's Asia expansion

By Angus Liu

The FDA's negative opinion toward Eli Lilly and Innovent Biologics' PD-1 application has broad implications for Chinese biopharmas eyeing the U.S. market and future PD-1/L1 programs. Novartis India plans to cut 400 jobs after a sales pact with Dr. Reddy's. Moderna will build four new commercial subsidiaries in Asia. And more.

Chutes & Ladders—Califf returns to FDA after narrow Senate confirmation

By Kyle LaHucik

Robert Califf, M.D., will once again helm the top spot at the FDA after a narrow confirmation by the Senate. The NIH's Vaccine Research Center Director John Mascola, M.D., will depart at the end of March after nearly 22 years at the center, including eight in the top spot. 2seventy bio poached Steven Bernstein, M.D., from Turnstone Biologics to fill the chief medical officer post.

LAST CHANCE TO SAVE: Fierce BD&L Summit for Life Sciences
March 15-16, 2022 | San Francisco, CA

This is your last chance to save $200 and attend the ONE life sciences event dedicated to the challenges faced by the professionals responsible for joint ventures, M&A, and licensing deals. Register now and Save!