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Tag: biotech


Biotech, Industry, Pharma

Quality Considerations for Using AI in Bio/Pharma

July 25, 2024

Via: Biopharm International

The use of artificial intelligence (AI) is seeing a surge in a variety of industries. But does the regulated nature of bio/pharmaceutical development, manufacturing, and commercialization serve up unique challenges for incorporating AI into processes? According to Siegfried Schmitt, vice-president, […]


Biotech, Industry

Private biotech M&A surges amid difficult IPO market

July 22, 2024

Via: Biopharma Dive

At the start of 2024, optimism had returned to biotech. Investor cash flowed back toward drug companies and initial public offerings, a useful barometer of the sector’s health, picked up in a sign of the market’s strengthening. But IPOs have […]


Biotech, Industry

Flagship raises $3.6B for biotech investing

July 10, 2024

Via: Biopharma Dive

Flagship’s robust funding round highlights a general recovery in biotech investment. A number of venture capital firms brought in fresh cash this year, including Foresite Capital, Sands Capital, Scion Life Sciences and a life sciences arm of Goldman Sachs. Arch […]


Biotech, Industry

Blackstone-backed biotech launches with up to $300M for immune drug

May 15, 2024

Via: Biopharma Dive

TSLP has become a popular target for drugmakers looking for new ways to tackle inflammation. Amgen and AstraZeneca entered the market first, after winning Food and Drug Administration approval in late 2021 for the asthma treatment Tezspire, an injection designed […]


Biotech, Industry

Sands Capital raises $555M fund amid upturn in biotech ‘crossover’ investing

May 14, 2024

Via: Biopharma Dive

Sands Capital has closed its latest life sciences investment fund, a $555 million haul that could help support biotechnology companies preparing to go public. The fund announced Tuesday, named Sands Capital Life Sciences Pulse Fund III, is the firm’s third […]


Biotech, Industry

Delphia starts up with $67M to make a new type of cancer drug

May 2, 2024

Via: Biopharma Dive

Cancer research is always evolving, as scientists search for ways to combat the tricks tumors use to evade drug therapies. In the last decade alone, immunotherapies, targeted therapies, antibody-drug conjugates and radiopharmaceuticals have become standard treatment for a variety of […]


Biotech, Industry

Biotech IPOs bounced back in first quarter, but backlog remains

April 12, 2024

Via: Biopharma Dive

Initial public offerings by biotechnology companies reached pre-pandemic levels during the first quarter, with nine drugmakers collectively raising more than $1.3 billion, according to BioPharma Dive data. The sum is more than three times the $375 million in total proceeds […]


Biotech, Cell and Gene Therapy, Industry

Century buys a startup, raises funding in cell therapy expansion

April 11, 2024

Via: Biopharma Dive

Drugmakers are moving quickly to study whether cell therapy, already a proven treatment for certain blood cancers, can tamp down autoimmune conditions, too. Lupus, a chronic disease that can cause inflammation and pain across the body, is one of the […]


Cell and Gene Therapy, Industry

BioCina and NovaCina to Partner on Drug Substance and Product Solutions for Biologics

March 1, 2024

Via: Biopharm International

BioCina, a biologics contract development and manufacturing organization (CDMO) and NovaCina, a global fill-and-finish CDMO, have announced a partnership to offer integrated drug substance and drug product solutions for biologics developers. This will allow BioCina to provide fill/finish services while […]


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 […]


News

Can a Moderna co-founder change the CRO game?

February 29, 2024

Via: Biopharma Dive

When you’re looking to make changes to how clinical trials are run, it’s helpful to work with one of the top minds in the industry. By welcoming Robert Langer to its advisory board, that’s exactly what Lindus Health hopes to […]


Cell and Gene Therapy, Industry

Cure Ventures backs a cell therapy startup targeting Parkinson’s

February 29, 2024

Via: Biopharma Dive

Kenai Therapeutics, a San Diego-based biotechnology company, has raised $82 million to support its work developing cell therapies for nervous system disorders. Cure Ventures, a new venture capital firm founded by three longtime biotech investors, co-led the Series A round […]


News

FDA approves Allecra’s combination antibiotic Exblifep for complicated UTIs

February 28, 2024

Via: PMLiVE

The antibiotic combination has been approved for adults with cUTIs, including the kidney infection pyelonephritis, which is most commonly caused by gram-negative bacteria. UTIs are a common infection and typically require antibiotics for treatment. Accounting for approximately 19% of all […]


FDA, Regulations

Say Goodbye to PFAS Chemicals in Food Packaging: FDA

February 28, 2024

Via: Drugs.com

PFAS “forever” chemicals, increasingly linked to health risks, will no longer be added to food packaging handled by American consumers, the U.S. Food and Drug Administration announced Wednesday. “Grease-proofing materials containing per- and polyfluoroalkyl substances [PFAS] are no longer being […]


Cell and Gene Therapy, Industry

Bayer receives U.S. FDA Breakthrough Therapy designation for BAY 2927088 for non-small cell lung cancer harboring HER2 activating mutations

February 27, 2024

Via: World Pharma News

Bayer announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for BAY 2927088 for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, […]


FDA, Regulations

Minerva schizophrenia drug rejected by FDA

February 27, 2024

Via: Biopharma Dive

The FDA’s decision sets back many years of effort by Minerva to secure approval of its drug for schizophrenia, called roluperidone and designed to treat so-called negative symptoms of the condition. The company, which licensed rights to roluperidone from Mitsubishi […]


News

UK biotech Curve swings £40.5m in Pfizer-backed round

February 27, 2024

Via: Pharmaphorum

The round was led by Pfizer’s investment arm Pfizer Ventures, with Columbus Venture Partners and British Patient Capital joining the round along with prior investors Advent Life Sciences and Epidarex Capita. The proceeds will be used to develop Curve’s Microcycle […]


FDA, Regulations

FDA approves Alvotech and Teva’s Simlandi as interchangeable Humira biosimilar

February 26, 2024

Via: PMLiVE

Simlandi has been approved by the regulator to treat rheumatoid arthritis, idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. Biosimilars, according to the FDA, are biological products that are highly similar to […]


News

NGM to go private through deal with investment firm

February 26, 2024

Via: Biopharma Dive

Founded in 2007, NGM took a broad approach to its drug research, assembling a pipeline that spans from solid tumors to retinal diseases to liver and metabolic disorders. NGM raised a few hundred million dollars in private funding before going […]


Cell and Gene Therapy, Industry

BioMarin preaches patience amid slow sales for hemophilia gene therapy

February 23, 2024

Via: Biopharma Dive

Roctavian’s approval was a scientific milestone, the culmination of years of research developing a genetic medicine for the chronic blood disease hemophilia A. Its launch, which began in Europe in 2022 and the U.S. last year, has been a focus […]