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Pricing, Regulations

AstraZeneca’s drug pricing lawsuit dismissed by federal judge

March 4, 2024

Via: Biopharma Dive

For the second time in less than a month, a federal court has rejected a pharmaceutical industry lawsuit challenging the drug pricing powers Medicare was granted by the Inflation Reduction Act. The U.S. District Court for the District of Delaware […]


FDA, Industry, Regulations, Vaccines

Vaccines Protect You & Your Kids From Measles: FDA

March 4, 2024

Via: Drugs.com

As new outbreaks of measles — a once nearly eliminated illness in the United States — continue to emerge, experts remind Americans that there’s an easy way to stop infection: Get vaccinated. “Measles spreads so easily that if one person […]


News

FDA approves Allecra’s combination antibiotic Exblifep for complicated UTIs

February 28, 2024

Via: PMLiVE

The antibiotic combination has been approved for adults with cUTIs, including the kidney infection pyelonephritis, which is most commonly caused by gram-negative bacteria. UTIs are a common infection and typically require antibiotics for treatment. Accounting for approximately 19% of all […]


FDA, Regulations

Say Goodbye to PFAS Chemicals in Food Packaging: FDA

February 28, 2024

Via: Drugs.com

PFAS “forever” chemicals, increasingly linked to health risks, will no longer be added to food packaging handled by American consumers, the U.S. Food and Drug Administration announced Wednesday. “Grease-proofing materials containing per- and polyfluoroalkyl substances [PFAS] are no longer being […]


FDA, Regulations

Minerva schizophrenia drug rejected by FDA

February 27, 2024

Via: Biopharma Dive

The FDA’s decision sets back many years of effort by Minerva to secure approval of its drug for schizophrenia, called roluperidone and designed to treat so-called negative symptoms of the condition. The company, which licensed rights to roluperidone from Mitsubishi […]


News

UK biotech Curve swings £40.5m in Pfizer-backed round

February 27, 2024

Via: Pharmaphorum

The round was led by Pfizer’s investment arm Pfizer Ventures, with Columbus Venture Partners and British Patient Capital joining the round along with prior investors Advent Life Sciences and Epidarex Capita. The proceeds will be used to develop Curve’s Microcycle […]


News

NGM to go private through deal with investment firm

February 26, 2024

Via: Biopharma Dive

Founded in 2007, NGM took a broad approach to its drug research, assembling a pipeline that spans from solid tumors to retinal diseases to liver and metabolic disorders. NGM raised a few hundred million dollars in private funding before going […]


FDA, Regulations

United sues FDA to try to block rival’s drug application

February 22, 2024

Via: Pharmaphorum

In an unusual move, United Therapeutics has filed a lawsuit against the FDA which claims the regulator is sidestepping established norms in allowing rival Liquidia to file for approval of a competitor to its Tyvaso product. The suit claims that […]


FDA, Regulations

FDA’s Drug Safety Priorities for 2023

February 21, 2024

Via: Biopharm International

On Feb. 15, 2024, FDA’s Center for Drug Evaluation and Research (CDER) released its report, Drug Safety Priorities FY23. The report describes the center’s key safety programs and activities involved in promoting and protecting public health and dealing with the […]


Clinical Trials, Research and Development

FDA puts hold on Rapt trials of drug for eczema, asthma

February 20, 2024

Via: Biopharma Dive

Analysts have followed Rapt as they view its drug, an oral pill dubbed zelnecirnon, as a possible competitor to Dupixent in conditions like eczema. Dupixent, which was developed by Sanofi and Regeneron, is a multibillion-dollar product approved for a range […]


Cell and Gene Therapy, Industry

AstraZeneca gets new Tagrisso OK as drug succeeds in another trial

February 20, 2024

Via: Biopharma Dive

Tagrisso is at the center of AstraZeneca’s oncology resurgence. The drug, which first won approval in the U.S. in 2015, is the company’s second highest selling product, after the diabetes and kidney disease treatment Farxiga. It has become a go-to […]


Clinical Trials, Research and Development

New initiative to improve patient retention in paediatric clinical trials

February 20, 2024

Via: Pharma Times

Innovative Trials has announced a new initiative designed to boost clinical trial patient retention in paediatric studies, in partnership with the Oliver Patch Project, a US charity. The Retention Patch Program is designed to engage directly with children and young […]


Biotech, Industry

Hunting a non-opioid painkiller, a biotech reveals plans to chase Vertex

February 14, 2024

Via: Biopharma Dive

A little over four years ago, biotechnology giant Amgen retreated from neuroscience research, halting much of its work developing treatments for diseases of the brain and trimming associated staff. Amgen’s pivot proved a boon for a small startup that was […]


Cell and Gene Therapy, Industry

BioNTech and Autolus enter CAR-T cell therapy collaboration worth over $250m

February 13, 2024

Via: PMLiVE

Both companies have entered into a license and option agreement, as well as a securities purchase agreement, in connection with the collaboration. Under the terms of the agreement, BioNTech will purchase $200m of Autolus’ US depositary shares in a private […]


Biotech, Industry

Alys launches with $100M and a pipeline of skin disease drugs

February 12, 2024

Via: Biopharma Dive

Six biotechnology startups are merging into a new skin drug developer called Alys Pharmaceuticals, which launched on Monday with $100 million from European life sciences investment firm Medicxi. Alys was formed out of the merger of a group of biotechs […]


Cell and Gene Therapy, Industry

Scientists develop micofluidic chip to make cell therapy safer

February 12, 2024

Via: Pharma Times

Researchers from the Massachusetts Institute of Technology (MIT) and the Singapore-MIT Alliance for Research and Technology have developed a plastic microfluidic chip to improve the safety and effectiveness of cell therapy treatments for patients living with spinal cord injuries. In […]


Cell and Gene Therapy, Industry

FDA fast-tracks GSK’s chronic hep B therapy bepirovirsen

February 12, 2024

Via: Pharmaphorum

The fast-track designation from the US regulator recognises that bepirovirsen is the only single agent in phase 3 that has shown the potential to achieve a “functional cure” when combined with standard CHB therapies based on oral nucleoside or nucleotide […]


Cell and Gene Therapy, Industry

AstraZeneca to invest $300M in US cell therapy plant

February 7, 2024

Via: Biopharma Dive

AstraZeneca is ramping up in cell therapy after a late entrance to the field. In 2022, it made its first significant acquisition in the area, buying up privately held Neogene Therapeutics. And the follow year, it formed a partnership with […]


Manufacturing, Research and Development

FDA Provides Guidance on Notifying the Agency of Manufacturing Interruptions

February 7, 2024

Via: Biopharm International

On Feb. 5, 2024, FDA announced it has published a draft guidance, Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, to assist applicants and manufacturers in notifying the agency about changes in […]


Industry, Vaccines

Vaccines May Work Better if Arms Are Alternated for Each Shot

February 6, 2024

Via: Drugs.com

When getting vaccines, switching arms for each dose may produce greater immunity than having the jabs delivered into the same arm. That’s the finding from a new study that looked at the first two doses of COVID vaccines. Those who […]