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Tag: drug manufacturing


Manufacturing, Mergers and Acquisitions, Research and Development

AGC Biologics and BioConnection Team Up on Biopharma Drug Development and Manufacturing

May 24, 2024

Via: Biopharm International

On May 22, 2024, AGC Biologics and BioConnection, a contract manufacturing organization specializing in aseptic filling of vials and syringes for clinical and commercial production, announced that they have entered into a new strategic partnership. Under the agreement, the companies […]


Manufacturing, Research and Development

Scientists reveal new method that could reduce waste from drug manufacturing

April 26, 2024

Via: Pharma Times

Scientists from the University of Edinburgh’s School of Chemistry have revealed a new sustainable method of manufacturing complex molecules that could reduce waste produced during drug production. The method published in Nature Chemistry could help to prevent severe side effects […]


Manufacturing, Research and Development

Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

April 10, 2024

Via: Biopharma Dive

The enrollment pause could affect at least one ongoing Phase 3 study of Novartis’ pill, which is approved for use in advanced and metastatic disease. That clearance is limited to people whose tumor can be treated with hormone drugs but […]


Mergers and Acquisitions

Lonza Acquires Roche’s US Commercial Biologics Manufacturing Site for $1.2 Billion

March 25, 2024

Via: Biopharm International

Lonza announced on March 20, 2024 that is has signed an agreement to acquire from Roche its Vacaville, Calif., site, a large-scale biologics manufacturing site, for $1.2 billion. Beyond the acquisition, Lonza plans to invest approximately CHF 500 million (US$557 […]


Manufacturing, Research and Development

Installation of Cytiva’s Aseptic Filling Workcell Aimed at Raising White Raven’s Manufacturing Efficiency

March 21, 2024

Via: Biopharm International

On March 19, 2024, Cytiva and White Raven, a Belgium-based contract development and manufacturing organization (CDMO), announced that White Raven has selected Cytiva’s SA25 Aseptic Filling Workcell for its fill/finish site. The installation of the workcell will complete White Raven’s […]


Manufacturing, Research and Development

Advanced technologies in unlocking the future of drug manufacturing

March 11, 2024

Via: Biopharma Dive

As the manufacturing landscape changes, it opens the door to pursuing hybrid opportunities that push the boundaries of technological advancement in the field. As an Industry Leader in two key domains: flow chemistry and biocatalysis, Asymchem has developed an innovative […]


News

Ensuring Contractors Perform Good Distribution Practices

March 1, 2024

Via: Biopharm International

The number of contractors and subcontractors involved in the supply chain for finished goods can be high, and their relationships very complex, particularly when goods are shipped by air or sea. Depending on the scope of the activity (e.g., whether […]


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 […]