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Tag: Pharmaceuticals


News

Pfizer takes stake in French Lyme disease jab partner Valneva

June 20, 2022

Via: Pharmaphorum

The deal gives Valneva a cash injection that it will be able to use to advance Lyme disease candidate VLA15 towards the market, but the revised licensing terms means that the French biotech will shoulder more of the financial cost […]


Clinical Trials, Research and Development

Pharmacy chain Walgreens plans to disrupt clinical trial sector

June 17, 2022

Via: Pharmaphorum

The company says it plans to use a “flexible” model, drawing on both decentralised trial (DCT) and conventional site-based models via its Health Corner and Village Medical outlets at various Walgreens locations across the US. The move follows in the […]


FDA, Regulations

FDA User Fee Legislation Advances in Senate

June 17, 2022

Via: Biopharm International

A broad bill carrying multiple proposals for revising and expanding FDA programs and policies, in addition to reauthorizing user fees critical for funding FDA operations, was endorsed by the Senate Health, Education, Labor and Pensions (HELP) Committee this week. The […]


Clinical Trials, Research and Development

Another amyloid miss in Alzheimer’s as Roche’s crenezumab fails trial

June 16, 2022

Via: Pharmaphorum

The result isn’t a big surprise – Roche terminated two phase 3 trials of crenezumab in people with prodromal to mild sporadic Alzheimer’s in early 2019 after interim analyses found it would be futile to continue – but is another […]


Industry, Manufacturing, Research and Development, Vaccines

EU governments pressure manufacturers to renegotiate contracts for COVID-19 vaccines

June 15, 2022

Via: PMLiVE

When vaccines became available earlier in the COVID-19 pandemic, countries vied for supply contracts. However, as the need for vaccines begins to slow in Europe, some countries want to amend their contracts to reduce spending and to prevent receiving more […]


Manufacturing, Research and Development

Alnylam wins FDA approval of rare disease drug in step toward profitability

June 14, 2022

Via: Biopharma Dive

Alnylam, a pioneer in the drugmaking method known as RNA interference, has climbed the biotech industry ranks over the last two decades. After solving challenges associated with delivering these treatments into the body, Alnylam has become one of the sector’s […]


FDA, Regulations

FDA Approves First Pill to Treat Severe Alopecia

June 14, 2022

Via: Drugs.com

The first pill to treat adults with severe alopecia was approved by the U.S. Food and Drug Administration on Monday. Olumiant (baricitinib) is the first FDA-approved alopecia therapy that treats the entire body rather than a specific spot, the agency […]


Industry, Vaccines

FDA staff supportive of Pfizer, Moderna COVID vaccines in young children

June 13, 2022

Via: Biopharma Dive

COVID-19 vaccines have been authorized in the U.S. for a year and a half, with the FDA progressively expanding their clearances to cover broader and broader swathes of the population. Yet they are still unavailable to the youngest children, who […]


Manufacturing, Research and Development

Resilience, a well-funded manufacturing startup, joins with the Parker Institute to make cancer drugs

June 9, 2022

Via: Biopharma Dive

While recent years have seen scientists make major advances in cutting-edge treatments such as gene and cell therapies, manufacturing remains a significant hurdle. The complex, multi-step processes required are beyond the capabilities of a traditional pharmaceutical plant. That’s where Resilience […]


Cell and Gene Therapy, Industry, Manufacturing, Research and Development

Regenxbio Opens Gene Therapy Manufacturing Facility

June 9, 2022

Via: Contract Pharma

Regenxbio recently celebrated the opening of its new Manufacturing Innovation Center gene therapy manufacturing facility. “Launching operations at our Manufacturing Innovation Center is an important milestone in the evolution of REGENXBIO,” said Kenneth T. Mills, president and CEO of REGENXBIO. […]


Manufacturing, Research and Development

Sana Biotechnology ditches California manufacturing plans in bid to save $100M

June 2, 2022

Via: FiercePharma

Sana Biotechnology, which raised a whopping $588 million in its initial public offering last year, has inked a deal for new manufacturing space. The preclinical-stage biotech is ditching plans to run its manufacturing operations in Fremont, California, and instead plans […]


News

Roche gambles $125M on a sliding biotech’s cancer drug

June 2, 2022

Via: Biopharma Dive

The most immediate effect of the deal is a much-needed infusion of funds for Repare, which went public in 2020 at a price of $20 a share. The company’s stock soared above $42 in early 2021, only to plummet as […]