Top

Tag: Pharmaceuticals


Industry, Vaccines

Americans Have One Trusted Source for Info on COVID Vaccines

February 8, 2024

Via: Drugs.com

A 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

Gene editing biotech Metagenomi pulls off nearly $94M IPO

February 8, 2024

Via: Biopharma Dive

CRISPR 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

FDA Provides Guidance on Notifying the Agency of Manufacturing Interruptions

February 7, 2024

Via: Biopharm International

On Feb. 5, 2024, FDA announced it has published a draft guidance, Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, to assist applicants and manufacturers in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 […]


News

Khosla Ventures’ Alex Morgan on biotech’s challenges and solving drug delivery

February 6, 2024

Via: Biopharma Dive

To 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 […]


Mergers and Acquisitions

More pharma M&A as Novartis snaps up MorphoSys for $2.9bn

February 6, 2024

Via: Pharmaphorum

The €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 […]


Industry, Vaccines

Positive efficacy results for R21/Matrix-M malaria vaccine published in The Lancet

February 5, 2024

Via: PMLiVE

R21, 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. […]


Industry, Pharma

Brain drug developer Alto Neuroscience prices $129M IPO

February 2, 2024

Via: Biopharma Dive

Another 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 […]


Biotech, Industry

Arch, a prolific biotech creator, is raising $3B for startup investing

February 2, 2024

Via: Biopharma Dive

Arch 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 […]


FDA, Regulations

FDA Warns of Dangerous Counterfeit Eyedrops

February 1, 2024

Via: Drugs.com

Certain 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

FDA Issues Guidance on CAR-T Cell Product Development

February 1, 2024

Via: Biopharm International

FDA 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 […]


News

Novo resumes supplying starter doses of obesity drug Wegovy

January 31, 2024

Via: Biopharma Dive

Novo 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, […]


FDA, Regulations

FDA Grants Orphan Drug Designation to First-in-Class Treatment for Eosinophilic Esophagitis

January 31, 2024

Via: Biopharm International

Revolo 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

CAR-T for lupus: the ‘tip of the iceberg’ for cell therapy in autoimmune disease

January 30, 2024

Via: Biopharma Dive

The 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 […]


Uncategorized

Fierce JPM Week: A Roundup of Biopharma’s Biggest Week

January 30, 2024

Via: Camila Mendes

For 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 […]


Biotech, Industry

Synnovation’s $102m round heads latest biotech financings

January 26, 2024

Via: Pharmaphorum

Wilmington, 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 […]


Industry, Pharma

At FDA meeting, experts wrestle with hurdles to developing preterm birth drugs

January 25, 2024

Via: Biopharma Dive

The 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

FDA orders new cancer warnings for CAR-T therapies

January 23, 2024

Via: Biopharma Dive

The 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 […]


Mergers and Acquisitions

Sanofi snaps up Inhibrx and its rare disease drug for $2.2bn

January 23, 2024

Via: Pharmaphorum

France’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 […]


Pricing, Regulations

Pharma CEOs may be subpoenaed as IRA dispute rumbles on

January 22, 2024

Via: Pharmaphorum

The 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 […]


Biotech, Industry

BridgeBio raises $1.25bn, and other biotech financings

January 19, 2024

Via: Pharmaphorum

Blue 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 […]