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Tag: Pharmaceuticals


Industry, Pharma

FDA turns down Satsuma’s nasal migraine treatment

January 19, 2024

Via: Pharmaphorum

The drug – a new dry powder intranasal formulation of the well-established migraine therapy dihydroergotamine mesylate (DHE) – was submitted for approval in the US last March as an easy-to-use, portable treatment option for acute migraine attacks, with or without […]


Mergers and Acquisitions

BridgeBio strikes drug royalty deal for cash infusion

January 18, 2024

Via: Biopharma Dive

BridgeBio Pharma has agreed to sell future royalties on an experimental rare disease drug in exchange for $500 million if the medicine, called acoramidis, receives Food and Drug Administration approval. The financing was extended by asset manager Blue Owl Capital […]


Biotech, Industry

A South Korean investment firm starts first US biotech fund

January 18, 2024

Via: Biopharma Dive

Mirae Asset Capital Life Science, a new venture capital fund, launched on Thursday, joining several other new firms that have recently emerged with plans to invest in drug startups. The fund is a spinout of Mirae Asset Financial Group, a […]


Industry, Pharma

CDER Approved 55 Novel Drugs in 2023

January 18, 2024

Via: Biopharm International

FDA’s Center for Drug Evaluation and Research (CDER) published its New Drug Therapy Approvals 2023 report on Jan. 16, 2024 highlighting new drugs approved in 2023. CDER approved 55 novel drugs during the year and expanded indications or patient populations […]


Mergers and Acquisitions

Bora Pharmaceuticals Fuels Global Expansion with Acquisition in US

January 17, 2024

Via: Biopharm International

Taiwan’s largest pharmaceutical manufacturer, Bora Pharmaceuticals, has announced the approval by its Board of Directors for the acquisition of generics manufacturer, Upsher-Smith, which is based in Minnesota, USA, for a total of $210 million. According to a Jan. 16, 2024 […]


Cell and Gene Therapy, Industry

First CRISPR drug Casgevy gets swift second approval

January 17, 2024

Via: Pharmaphorum

Casgevy (exagamglogene autotemcel or exa-cel) became the first drug based on the CRISPR/Cas9 gene-editing technology to be approved towards the end of last year, when it was cleared by the FDA for sickle cell disease (SCD). The UK was the […]


Industry, Pharma

AI could revolutionise pharma compound synthesis

January 16, 2024

Via: Pharmaphorum

Their novel approach to high-throughput experimentation (HTE) could do away with the current need to run trial-and-error experiments to see how chemicals used to make medicines react with one another, predicting their behaviour virtually, and has been described in a […]


FDA, Regulations

FDA says no ‘clear relationship’ between GLP-1 drugs and suicide risk

January 12, 2024

Via: Biopharma Dive

The concerns over suicide ideation — thinking about or planning suicide — emerged last year when the Icelandic drug agency reported to the EMA two cases in people taking GLP-1s. One was taking Saxenda, Novo Nordisk’s daily weight-loss shot, and […]


Cell and Gene Therapy, Industry

Bayer unit takes heart failure gene therapy into phase 2

January 12, 2024

Via: Pharmaphorum

The new GenePHIT study is enrolling patients with non-ischaemic cardiomyopathy and New York Heart Association (NYHA) class III heart failure who have been medically stable for at least 4 weeks. People with this stage of CHF will have a marked […]


Biotech, Industry

Newly optimistic, biotech investors weigh lessons of sector’s downturn

January 11, 2024

Via: Biopharma Dive

The J.P. Morgan Healthcare Conference, a yearly temperature taker for the biotechnology industry, had a different feel in 2024. For the first time in awhile, young drugmakers and their backers were optimistic the sector’s downturn might finally be over. An […]


FDA, Regulations

FDA to Import Syphilis Drug, Extencilline, From France Amid Shortage

January 11, 2024

Via: Drugs.com

Amid an ongoing shortage of the first-line treatment for syphilis in the United States, the U.S. Food and Drug Administration will allow the importation of a different syphilis drug from a French drugmaker. In a letter from Laboratoires Delbert, the […]


Industry, Vaccines

Barinthus Bio announces $47m project to advance MERS coronavirus vaccine

January 10, 2024

Via: Pharma Times

Barinthus Biotherapeutics has announced a new partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford to advance a vaccine against Middle East respiratory syndrome (MERS). The partnership aims to fast-track the development of Barinthus Bios’ […]


Industry, Pharma

5 questions facing pharma in 2024

January 10, 2024

Via: Biopharma Dive

The arrival of powerful new drugs for obesity has reshaped the pharmaceutical industry, transforming Eli Lilly and Novo Nordisk into the sector’s most valuable companies and sending others scrambling to catch up. Analysts predict that so-called GLP-1 drugs like Lilly’s […]


News

Merck pays $680M for struggling cancer biotech Harpoon

January 8, 2024

Via: Biopharma Dive

In 2028, Merck faces the possible loss of market exclusivity for its biggest product, Keytruda, which accounted for nearly half of its pharmaceutical revenue over the first nine months of 2023. Aiming to maintain its market share, Merck has been […]


News

An unusual drugmaker raises north of $100M for ecstasy-based PTSD therapy

January 5, 2024

Via: Biopharma Dive

A California-based company has raised tens of millions of dollars to support its mission of bringing an ecstasy-based therapy to patients with post-traumatic stress disorder. MAPS Public Benefit Corp. formed a decade ago as a subsidiary of the Multidisciplinary Association […]


Pricing, Regulations

FDA Gives Florida OK to Import Cheaper Drugs From Canada

January 5, 2024

Via: Drugs.com

The U.S. Food and Drug Administration on Friday gave the nod to a Florida plan to import drugs from Canada at much lower prices than in the United States. The approval could prove to be a major turning point for […]


News

FDA ends busy year with three drug rejections

January 2, 2024

Via: Biopharma Dive

The Food and Drug Administration closed out 2023 with rejections of three drugmaker applications for first approval or expanded use, handing Amgen, Zealand Pharma and Merck & Co. complete response letters for medicines to treat cancer, low blood sugar and […]


Industry, Vaccines

Could Antibody Discovery Lead to Better Flu Vaccines?

December 29, 2023

Via: Drugs.com

Researchers appear to have discovered a new weapon in the war on a particularly difficult foe. They have identified a previously unrecognized class of antibodies that seem to be capable of neutralizing multiple strains of the flu virus. Their findings, […]


Clinical Trials, Research and Development

Cytokinetics rockets on positive heart drug trial

December 28, 2023

Via: Pharmaphorum

Treatment with the cardiac myosin inhibitor significantly improved exercise capacity in patients with obstructive hypertrophic cardiomyopathy (HCM), an inherited disorder in which the heart muscle becomes thickened and can obstruct blood flow. It is one of the most common reasons […]


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 […]