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Mergers and Acquisitions

NewAmsterdam Pharma and Frazier LifeSciences announce merger agreement

July 26, 2022

Via: PMLiVE

Upon closing of the transaction, a newly formed holding company, NewAmsterdam Pharma Company NV, will be led by Michael Davidson, chief executive officer of the company. The Dutch biotech will receive approximately $235m from a private placement led by Frazier […]


Biotech, Industry

‘Flat is the new up’: After biotech correction, venture investors turn to safer bets

July 26, 2022

Via: Biopharma Dive

Agios Pharmaceuticals needed money. It was 2010 and Agios, like many other biotechnology startups then, was trying to survive following a global recession. Venture capital was contracting, leaving emerging companies with fewer financing options. Initial public offerings, a main source of […]


FDA, Regulations

FDA, in another test of its flexibility, agrees to review Biogen’s closely watched ALS drug

July 26, 2022

Via: Biopharma Dive

Late last year, Biogen disclosed results from a closely watched study evaluating an experimental drug for Lou Gehrig’s disease, also known as ALS or amyotrophic lateral sclerosis. They showed the drug, called tofersen, wasn’t better than a placebo at slowing progression of […]


Biotech, Industry, Vaccines

ExcellGene, Bharat Biotech & University of Sydney to Develop Variant-Proof SARS-CoV-2 Vaccine

July 26, 2022

Via: Contract Pharma

ExcellGene SA, privately held and founded 2001, has announced its role in the recently approved consortium funding through the Coalition for Epidemic Preparedness Innovations (CEPI), a global partnership of public, private, philanthropic and civil society organizations founded to develop vaccines […]


FDA, Regulations

AstraZeneca, Daiichi breast cancer drug set for speedy FDA review

July 25, 2022

Via: Biopharma Dive

The Food and Drug Administration has agreed to quickly review AstraZeneca and Daiichi Sankyo’s drug Enhertu for treating metastatic breast cancer that expresses low levels of a protein known as HER2. If approved, the therapy would become the first targeted […]


Cell and Gene Therapy, Industry

Next-level quality control in cell and gene therapy

July 25, 2022

Via: Biopharma Dive

Cell and gene therapies are taking the world by storm. With CRISPR gene-editing technology, the genome is no longer an untouchable sacred text. Instead, genomic DNA is actively manipulated in the laboratory and the clinic. This revolution is changing the […]


Pricing, Regulations

Ad Targeting Manchin and AARP Mischaracterizes Medicare Drug-Price Negotiations

July 25, 2022

Via: Kaiser Health News

A snappy political advertisement from the conservative advocacy group American Commitment bluntly charges Sen. Joe Manchin (D-W.Va.) with supporting a legislative plan that would drain “billions in funds” from Medicare. Specifically, the ad claims that Manchin and AARP, the well-known advocacy group for people […]


Industry, Pharma

Sandoz’s application for MS biosimilar accepted by FDA

July 25, 2022

Via: PMLiVE

The application incorporates all indications covered by the reference medicine, Biogen’s Tysabri (natalizumab), for relapsing forms of MS, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), active secondary progressive disease in adults and Crohn’s disease. A marketing authorisation application (MAA) […]


Editorial

New Drugs Could Help Patients with Serious Brain Disorders

July 22, 2022

Via: Natalie Dunn

While the COVID-19 pandemic wreaked havoc and forced scientists and policymakers to create or search for vaccines and treatments, common disorders continued to affect millions of human lives. The pandemic made it harder for people suffering from chronic conditions to […]


Industry, Vaccines

Vicebio targets development of novel vaccines

July 22, 2022

Via: Pharma Times

Vicebio has announced its aim to accelerate the development of novel vaccines against life-threatening respiratory viral infections using its novel molecular clamp technology platform. The technology has been developed by Professor Paul Young, Dr Daniel Watterson, Dr Keith Chappell and […]


Industry, Pharma, Pricing, Regulations

Pfizer, Flynn fined £70m in resurrected epilepsy drug pricing probe

July 22, 2022

Via: Pharmaphorum

The CMA delivered a preliminary judgment in the case last year which concluded that Pfizer and Flynn abused a dominant position in phenytoin sodium capsules, causing NHS spending on the drug to balloon from around £2 million a year in 2012 to […]


FDA, Regulations

FDA to Take a Hard Look at Its Food, Tobacco Programs

July 21, 2022

Via: Drugs.com

The U.S. Food and Drug Administration will begin a comprehensive review of its food and tobacco programs amid a high-profile infant formula shortage and recent rulings on e-cigarettes. FDA Commissioner Robert Califf first announced the review on Tuesday, then appeared […]


Industry, Pharma

Parents Become Drug Developers to Save Their Children’s Lives

July 21, 2022

Via: Kaiser Health News

Maggie Carmichael wasn’t developing like other kids. As a toddler, she wasn’t walking and had a limited vocabulary for her age. She was diagnosed with PMM2-CDG, potentially fatal gene mutations that cause abnormal enzyme activity — and affect fewer than […]


News

Assembly Bio scraps hepatitis B drug, cuts staff after clinical setback

July 21, 2022

Via: Biopharma Dive

While the study failures are a significant setback for Assembly, they’re not a major surprise for a company whose market value has hovered around $100 million, Jefferies analyst Dennis Ding wrote in a note to clients. “The Street didn’t expect […]


Cell and Gene Therapy, Industry

VBL craters as ovarian cancer gene therapy fails phase 3 test

July 20, 2022

Via: Pharmaphorum

Shares in VBL Therapeutics have lost around 78% of their value in pre-market trading after the company reported a phase 3 trial of its lead gene therapy VB-111 for ovarian cancer failed a pivotal trial. In the OVAL study, VB-111 […]


Industry, Vaccines

Biopharma industry launches Berlin Declaration to ensure equal access during future pandemics

July 20, 2022

Via: PMLiVE

The biopharmaceutical industry has launched a declaration proposing a joint solution to global leaders that could help to ensure equitable access to vaccines and treatments for future pandemics. The ‘Berlin Declaration – biopharmaceutical industry vision for equitable access in pandemics’ […]


Cell and Gene Therapy, Industry

Roche digs deeper into gene therapy for the eye

July 20, 2022

Via: Biopharma Dive

Roche is putting more money into gene therapies for eye diseases, announcing a deal to work with University of Pittsburgh spinout Avista Therapeutics to develop better delivery tools for the complex treatments. Through the deal, Avista will develop new capsids, […]


News

UK scientists say they have found cancer driver in junk DNA

July 20, 2022

Via: Pharmaphorum

It has suspected for many years that some diseases may be linked to non-coding or ‘junk’ DNA, but the mechanism behind the pathology hasn’t been worked out. Now, scientists in the UK think they have found a culprit implicated in […]


Manufacturing, Research and Development

Cytiva Acquires Chromatography Resins Manufacturing Facility in Muskegon, Michigan

July 19, 2022

Via: Biopharm International

Cytiva has acquired a new chromatography resins manufacturing site in the United States as part of its $1.5 billion capacity expansion investment. Cytiva announced on July 13, 2022 that it had acquired a new manufacturing facility in Muskegon, MI. The […]


FDA, Regulations

FDA clears Incyte’s Opzelura as first vitiligo therapy

July 19, 2022

Via: Pharmaphorum

Incyte’s Opzelura cream has become the first medical treatment approved to re-pigment the skin of people with vitiligo in the US, adding to its current use in atopic dermatitis. The FDA’s decision to clear the new indication for the topical […]