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Tag: Pharmaceuticals


Mergers and Acquisitions

AZ makes another cell therapy play with $1.2bn Gracell buy

December 26, 2023

Via: Pharmaphorum

The agreement is the latest in a series of acquisitions and licensing deals aimed at bolstering AZ’s position in cell therapy, an area where it has lagged behind other companies like Novartis, Bristol-Myers Squibb, and Gilead Sciences, and also continues […]


Industry, Vaccines

BioNTech wins round in CureVac mRNA patent dispute

December 20, 2023

Via: Pharmaphorum

The validity of the patent is at the heart of patent litigation between CureVac and fellow German biotech BioNTech and its partner Pfizer, claiming infringement by their Comirnaty coronavirus shot. CureVac – which is developing mRNA-based vaccines for COVID-19 and […]


FDA, Regulations

FDA says no to Checkpoint’s skin cancer drug cosibelimab

December 19, 2023

Via: Pharmaphorum

Checkpoint Therapeutics’ late entry into the PD-1/PD-L1 inhibitor category, cosibelimab, just got knocked back even further after it was turned down by the FDA as a treatment for skin cancer. A complete response letter (CRL) from the US regulator cites […]


Editorial

The A-Z of AstraZeneca’s Billion Dollar Acquisition

December 18, 2023

Via: Camila Mendes

With a $1.2 billion dollar acquisition of Gracell Biotechnologies, pharmaceutical giant AstraZeneca has firmly entrenched itself in the Asian market. The company is not only expanding its footprint, but also broadening its scope with its foray into cell therapy—Gracell’s specialized […]


Industry, Pharma

Structure shares sink as obesity pill misses expectations in small study

December 18, 2023

Via: Biopharma Dive

An experimental obesity pill being developed by Structure Therapeutics helped lower the blood sugar levels of people with Type 2 diabetes in a clinical trial, but didn’t match the degree of weight loss observed in testing of a rival medicine. […]


News

Hemgenix first drug to clear France’s ‘direct access’ route

December 14, 2023

Via: Pharmaphorum

The route – which is being piloted for two years – allows drugs deemed to be innovative and with a major medical benefit by the Haute Autorité de Santé (HAS) to be made eligible for reimbursement by French social security […]


FDA, Regulations

FDA Asked to Consider Party Drug MDMA as Treatment for PTSD

December 13, 2023

Via: Drugs.com

A California company has asked the U.S. Food and Drug Administration to approve MDMA, the active ingredient in party drugs like molly and ecstasy, as a treatment for post-traumatic stress disorder (PTSD). When announcing the new drug application (NDA) filing […]


Mergers and Acquisitions

AZ agrees $1.1bn deal to buy RSV jab developer Icosavax

December 12, 2023

Via: Pharmaphorum

The $15-per-share deal is a 43% premium to Icosavax’s closing share price yesterday and values the company at around $1.1 billion, of which $800 million is payable near-term, with the remainder tied to certain future achievements. It is due to […]


Industry, Pharma

ASH23: Pharma branding, Editas’ high bar and clinical trial diversity

December 11, 2023

Via: Biopharma Dive

At the American Society of Hematology’s annual meeting, pharmaceutical branding is inescapable. Johnson & Johnson’s and GSK’s new logos are splashed across the side of phone charging stations. Sanofi, among others, let attendees know via hand sanitizer stands that it […]


Pricing, Regulations

Biden may order compulsory licensing in drug pricing move

December 7, 2023

Via: Pharmaphorum

The proposed framework for so-called ‘march-in rights’ on taxpayer-funded drugs and other inventions is the latest entry in the US federal government’s playbook to limit price increases for drugs, and will no doubt throw it once again into open contention […]


News

Colorado Blames Biden Team and Drugmakers for Delaying Canadian Imports

December 7, 2023

Via: Kaiser Health News

Colorado officials say their plan to import cheaper medicines from Canada has been stymied by opposition from drugmakers and inaction by the Biden administration, according to a state report obtained by KFF Health News. The Dec. 1 report, prepared for […]


News

FDA starts review of Padcev/Keytruda for bladder cancer

December 1, 2023

Via: Pharmaphorum

The agency is due to deliver a verdict on the combination by 9th May next year and, if approved, it could be an alternative to first-line chemotherapy for all patients with this form of cancer. Nectin-4-targeting antibody-drug conjugate Padcev (enfortumab […]


FDA, Regulations

FDA elevates chief scientist Bumpus to the number two role

November 30, 2023

Via: Pharmaphorum

Bumpus is heading for the number two position at the FDA – second only to Commissioner Robert Califf, who announced the appointment on X (formerly Twitter) – just over a year after she joined the agency. “As principal deputy commissioner, […]


Cell and Gene Therapy, Industry

Stem cell therapy trial shows promising results for treating progressive MS

November 28, 2023

Via: PMLiVE

Results from the trial show potential for developing an advanced cell therapy treatment for the condition. Affecting around two million people globally, MS is a neurodegenerative condition that affects the brain and spinal cord. Around two-thirds of people with MS […]


Clinical Trials, Research and Development

AstraZeneca announces launch of new healthtech business Evinova to optimise clinical trials

November 21, 2023

Via: PMLiVE

Evinova will aim to better meet the needs of healthcare professionals, regulators and patients. The new healthtech business aims to bring to market established and scaled digital technology solutions which are already used globally by AZ, to pharmaceutical, biotechnology and […]


Mergers and Acquisitions

Merck to buy private biotech Caraway in neuroscience deal

November 21, 2023

Via: Biopharma Dive

Caraway raised a small Series A round of $23 million in 2018, backed by several pharmaceutical venture arms, including Merck’s. At the time, the company went by the name of Rheostat Therapeutics. It rebranded to Caraway one year later, but […]


Manufacturing, Research and Development

Data infrastructure excellence changing the shape of biopharma manufacturing

November 20, 2023

Via: Biopharma Dive

In biopharma manufacturing, there is a fine line between being data rich and information poor. Sites are filled with disparate systems, increasing the potential for siloed data. But since data is so key, biopharma companies must find better ways to […]


Cell and Gene Therapy, Industry

Bristol Myers faces FDA delay on cancer cell therapy decision

November 20, 2023

Via: Biopharma Dive

Last month, Bristol Myers delivered unwanted news, telling investors that sales of new drugs it’s counting on this decade will grow more slowly than expected. One of the chief culprits for that guidance shift was Abecma, sales of which dropped […]


Manufacturing, Research and Development

Accelerating Lentivirus Manufacturing: Choosing the Right Plasmid Manufacturing Platform

November 17, 2023

Via: Biopharm International

Plasmid DNA is a critical raw material that is required for the manufacturing of virus-based gene therapy and gene-modified cell therapies. The current challenges with the supply of plasmid DNA varies depending on its end use, but usually production capacity, […]


FDA, Regulations

FDA approves new Bristol Myers drug for lung cancer

November 16, 2023

Via: Biopharma Dive

The arrival of immunotherapies like Merck & Co.’s Keytruda and Bristol Myers’ Opdivo transformed the treatment of lung cancer. But for patients with uncommon mutations like ROS1, ALK, KRAS and EGFR, targeted drugs are a first choice for physicians. The […]