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 […]
Cell and Gene Therapy, Industry
February 8, 2024
Via: Biopharma DiveCRISPR gene editing captured headlines in recent months with the landmark approval of Casgevy, the first medicine made from the Nobel Prize-winning technology. But that milestone was only part of a larger story, of which an emerging generation of drugmakers […]
Manufacturing, Research and Development
February 7, 2024
Via: Biopharm InternationalOn Feb. 5, 2024, FDA announced it has published a draft guidance, Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, to assist applicants and manufacturers in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 […]
February 6, 2024
Via: Biopharma DiveTo hear venture capitalist Alex Morgan tell it, investors shouldn’t be in the business of predicting trends. “There’s often a public perception that we’re in the prediction game,” said Morgan, a partner at Khosla Ventures who oversees the firm’s biotechnology […]
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: Biopharma DiveAnother biotechnology company has hit Wall Street via an initial public offering, the third to do so this year in an uptick of IPO activity that suggests rebounding investor interest in life sciences stocks. Alto Neuroscience raised about $129 million […]
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 […]
February 1, 2024
Via: Drugs.comCertain copycat eyedrops may be contaminated and could give users an antibiotic-resistant eye infection, the U.S. Food and Drug Administration warned Wednesday. The packaging for South Moon, Rebright and FivFivGo eyedrops mirrors the packaging for Bausch & Lomb’s Lumify eyedrops, […]
Cell and Gene Therapy, Industry
February 1, 2024
Via: Biopharm InternationalFDA published final guidance on Jan. 30, 2024 that provides consideration for the development of chimeric antigen receptor (CAR) T-cell products. According to FDA, “[CAR T-cell] products are human gene therapy products in which the T cell specificity is genetically […]
January 31, 2024
Via: Biopharma DiveNovo Nordisk has resumed shipping starter doses of its weight-loss drug Wegovy, nearly nine months after manufacturing problems forced it to restrict distribution to maintenance shots in order to ensure that people who had already started taking it could continue, […]
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 30, 2024
Via: Camila MendesFor the biopharma industry, the start of the year holds one of the biggest events in the global industry calendar, JPM Week. It’s the ultimate meeting of minds, bringing together scientists, pharmaceutical industry professionals, bankers, investors, startup founders, journalists, and […]
January 26, 2024
Via: PharmaphorumWilmington, Delaware-based Synnovation, a specialist in small-molecule therapeutics for cancer, has emerged from the shadows with a $102 million first-round financing led by Third Rock Ventures with participation from Nextech, Lilly Asia Ventures, Sirona Capital and Cormorant Asset Management. The […]
January 25, 2024
Via: Biopharma DiveThe Food and Drug Administration this week convened a group of experts to discuss ways to develop new drugs for preventing spontaneous early births, a major health concern for which there are no good treatments. At the two-day workshop led […]
Cell and Gene Therapy, Industry
January 23, 2024
Via: Biopharma DiveThe CAR-T therapies — Abecma and Breyanzi from Bristol Myers Squibb, Carvykti from Johnson & Johnson and Legend Biotech, Kymriah from Novartis, and Tecartus and Yescarta from Gilead — can drive deep and durable responses in patients with lymphoma, leukemia […]
January 23, 2024
Via: PharmaphorumFrance’s Sanofi – a major player in the rare disease category – is offering $30 per share for La Jolla, California-based Inhibrx, which had a closing price of just over $33 yesterday. The cash deal values the company at $1.7 […]
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 19, 2024
Via: PharmaphorumBlue Owl Capital and Canada Pension Plan Investment Board have stepped in to bulk up cash reserves at BridgeBio as it prepares for the launch of acoramidis for transthyretin amyloid cardiomyopathy (ATTR-CM) and a market showdown with much larger rival […]