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Cell and Gene Therapy, Industry

Scientists develop micofluidic chip to make cell therapy safer

February 12, 2024

Via: Pharma Times

Researchers from the Massachusetts Institute of Technology (MIT) and the Singapore-MIT Alliance for Research and Technology have developed a plastic microfluidic chip to improve the safety and effectiveness of cell therapy treatments for patients living with spinal cord injuries. In […]


Cell and Gene Therapy, Industry

FDA fast-tracks GSK’s chronic hep B therapy bepirovirsen

February 12, 2024

Via: Pharmaphorum

The fast-track designation from the US regulator recognises that bepirovirsen is the only single agent in phase 3 that has shown the potential to achieve a “functional cure” when combined with standard CHB therapies based on oral nucleoside or nucleotide […]


FDA, Regulations

How Would an FDA Ban on Popular Cold Meds Affect Americans?

February 9, 2024

Via: Drugs.com

America’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 […]


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 […]


Cell and Gene Therapy, Industry

AstraZeneca to invest $300M in US cell therapy plant

February 7, 2024

Via: Biopharma Dive

AstraZeneca is ramping up in cell therapy after a late entrance to the field. In 2022, it made its first significant acquisition in the area, buying up privately held Neogene Therapeutics. And the follow year, it formed a partnership with […]


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 […]


Industry, Vaccines

Vaccines May Work Better if Arms Are Alternated for Each Shot

February 6, 2024

Via: Drugs.com

When 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 […]


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 […]


Mergers and Acquisitions

Biovian and 3P Biopharmaceuticals Combine to Form 3PBIOVIAN

February 5, 2024

Via: Biopharm International

Biovian, a contract development and manufacturing organization (CDMO), announced on Feb. 1, 2024 that it was combining with CDMO 3P Biopharmaceuticals to form 3PBIOVIAN under the two companies’ common shareholder, Keensight Capital. The new group, 3PBIOVIAN, will offer end-to-end development […]


Cell and Gene Therapy, Industry

4DMT gene therapy cuts need for Eylea in wet AMD trial

February 5, 2024

Via: Pharmaphorum

On the strength of the results, 4DMT is planning to start a phase 3 trial of the gene therapy by the end of the first quarter of 2025. The data from the phase 2 PRISM study comes from a cohort […]


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 […]


News

FDA sets date for Adaptimmune’s sarcoma drug verdict

February 2, 2024

Via: Pharmaphorum

If 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 […]


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 […]


Cell and Gene Therapy, Industry

Regeneron Forms R&D Cell Therapy Unit from 2seventy bio Platform Acquisition

February 1, 2024

Via: Biopharm International

On Jan. 30, 2024, Regeneron Pharmaceuticals (Regeneron) announced the formation of a new R&D unit, Regeneron Cell Medicines, founded on an agreement with 2seventy bio, a US-based immuno-oncology cell therapy company. Under the agreement, Regeneron acquires full development and commercialization […]


Editorial

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

January 31, 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 […]