FDA, Industry, Regulations, Vaccines
March 4, 2024
Via: Drugs.comAs 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 […]
February 29, 2024
Via: Caitlin SimmonsWelcome to the land of biopharmaceuticals, where the wonders of medicine meet with the intricacies of distribution networks. The biopharma sector is blazing a trail in creating life-saving medications, vaccines, and treatments. These aren’t merely commodities, they serve as support […]
February 27, 2024
Via: PharmaphorumThe 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 […]
February 22, 2024
Via: PharmaphorumIn 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 […]
February 21, 2024
Via: Biopharm InternationalOn 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
February 20, 2024
Via: Pharma TimesInnovative 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 […]
February 9, 2024
Via: Drugs.comAmerica’s most popular cold medications contain a nasal decongestant that doesn’t work, creating a knotty dilemma for regulators, a new study reports. Cold remedies containing phenylephrine remain consumers’ most popular choice, despite decades of concern that the decongestant simply isn’t […]
February 8, 2024
Via: Drugs.comA doctor or nurse might be the only person capable of convincing a vaccine-hesitant person to get the COVID jab, a new study shows. Those who trust the medical profession are most likely to get vaccinated against COVID, despite their […]
February 6, 2024
Via: Drugs.comWhen 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 […]
February 6, 2024
Via: PharmaphorumThe €68-per-share cash offer has been approved by the boards of both companies, who say they expect it to be completed in the latter half of the year, subject to the usual regulatory approvals and other closing conditions. MorphoSys’ share […]
February 5, 2024
Via: PMLiVER21, which uses an adjuvant developed by Novavax to boost immune response, became the second malaria vaccine to be prequalified by the World Health Organization’s (WHO) in December 2023, following the organisation’s prequalification of the RTS,S/AS01 vaccine in July 2022. […]
February 2, 2024
Via: PharmaphorumIf the biologics license application (BLA) is approved, afami-cel will become the first engineered T-cell therapy for solid tumours and the first effective treatment option for advanced synovial sarcoma in more than a decade, according to the Anglo-American company. Synovial […]
February 2, 2024
Via: Biopharma DiveArch Venture Partners, one of the biotechnology sector’s most prolific company creators, is raising a new $3 billion fund, according to a regulatory filing. The fund, which would be Arch’s 13th, is being put together less than two years after […]
January 31, 2024
Via: Biopharm InternationalRevolo Biotherapeutics announced on Jan. 30, 2024 that FDA has granted Orphan Drug Designation to ‘1104, a first-in-class immune-resetting peptide being developed as a potential treatment for eosinophilic esophagitis (EoE). Revolo focuses on developing therapies that reset the immune system […]
Cell and Gene Therapy, Industry
January 30, 2024
Via: Biopharma DiveThe clue came, as they often do, from an unexpected source. Some sixteen months ago, a small study of five people in Germany pointed to a new direction for the high-profile field of cell therapy. The study showed a cellular […]
January 22, 2024
Via: Pharma TimesThe NHS has announced the launch of its new catch up campaign to get millions of children booked in for their missed measles, mumps and rubella (MMR) vaccine. The new campaign aligns with the health services efforts to protect children […]
January 22, 2024
Via: PharmaphorumThe independent Vermont lawmaker is calling on J&J’s Joaquin Duato and Merck’s Robert Davis to explain personally why their medicines generally cost much more in the US. The two CEOs refused to testify in front of the HELP committee last […]
January 17, 2024
Via: Biopharm InternationalTaiwan’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 […]
January 11, 2024
Via: Biopharma DiveThe 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 […]
January 10, 2024
Via: Pharma TimesBarinthus 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’ […]