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Tag: drug manufacturing


FDA, Regulations

FDA’s Drug Safety Priorities for 2023

February 21, 2024

Via: Biopharm International

On 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 […]


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 […]


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On Feb. 5, 2024, FDA announced it has published a draft guidance, Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, to assist applicants and manufacturers in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


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 […]


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 […]


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 […]


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 […]


Pricing, Regulations

FDA authorises Florida’s request to import cheaper prescription drugs from Canada

January 9, 2024

Via: PMLiVE

Prescription drug pricing has been an ongoing issue in the US, which is reportedly spending more than double the average amount spent by other OECD member countries on prescription medicines per capita. Florida’s Canadian Prescription Drug Importation Program, which will […]


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 […]


FDA, Regulations

5 FDA decisions to watch in the first quarter

January 4, 2024

Via: Biopharma Dive

Biotechnology is often described as an “innovation” industry, dependent on companies’ ability to invent and develop new medicines. By that metric, 2023 was a good year. The FDA’s main review office approved 55 novel drugs, the most since 2018, while […]


News

Hemgenix first drug to clear France’s ‘direct access’ route

December 14, 2023

Via: Pharmaphorum

The route – which is being piloted for two years – allows drugs deemed to be innovative and with a major medical benefit by the Haute Autorité de Santé (HAS) to be made eligible for reimbursement by French social security […]


Industry, Pharma

ASH23: Pharma branding, Editas’ high bar and clinical trial diversity

December 11, 2023

Via: Biopharma Dive

At the American Society of Hematology’s annual meeting, pharmaceutical branding is inescapable. Johnson & Johnson’s and GSK’s new logos are splashed across the side of phone charging stations. Sanofi, among others, let attendees know via hand sanitizer stands that it […]


Pricing, Regulations

Biden may order compulsory licensing in drug pricing move

December 7, 2023

Via: Pharmaphorum

The proposed framework for so-called ‘march-in rights’ on taxpayer-funded drugs and other inventions is the latest entry in the US federal government’s playbook to limit price increases for drugs, and will no doubt throw it once again into open contention […]


News

Colorado Blames Biden Team and Drugmakers for Delaying Canadian Imports

December 7, 2023

Via: Kaiser Health News

Colorado officials say their plan to import cheaper medicines from Canada has been stymied by opposition from drugmakers and inaction by the Biden administration, according to a state report obtained by KFF Health News. The Dec. 1 report, prepared for […]


Cell and Gene Therapy, Industry

Fujifilm to invest $200M in cell therapy production

December 6, 2023

Via: Biopharma Dive

Fujifilm said Tuesday it will invest $200 million in cell therapy manufacturing, earmarking the new funds for an area of drug research it expects to grow considerably in the coming years. The investments will go to two subsidiaries focused on […]


Manufacturing, Research and Development

Accelerating Lentivirus Manufacturing: Choosing the Right Plasmid Manufacturing Platform

November 17, 2023

Via: Biopharm International

Plasmid DNA is a critical raw material that is required for the manufacturing of virus-based gene therapy and gene-modified cell therapies. The current challenges with the supply of plasmid DNA varies depending on its end use, but usually production capacity, […]


FDA, Regulations

FDA approves new Bristol Myers drug for lung cancer

November 16, 2023

Via: Biopharma Dive

The arrival of immunotherapies like Merck & Co.’s Keytruda and Bristol Myers’ Opdivo transformed the treatment of lung cancer. But for patients with uncommon mutations like ROS1, ALK, KRAS and EGFR, targeted drugs are a first choice for physicians. The […]