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Tag: Pharmaceuticals


News

After Clinical Setbacks, Theravance Axes 75% of Workforce and Refocuses on Respiratory Drugs

September 16, 2021

Via: Genetic Engineering and Biotechnology News

Intent on bouncing back from a pair of later-phase clinical trial failures, Theravance Biopharma said it will eliminate about 75% of its workforce—270 jobs—and slash its R&D budget next year through a restructuring that will refocus the company on respiratory […]


Industry, Vaccines

Moderna Highlights New Clinical Data on its COVID-19 Vaccine

September 15, 2021

Via: Drugs.com

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today highlighted a new analysis suggesting that the Moderna COVID-19 vaccine is highly effective against circulating variants of concern, including in a vaccine effectiveness study conducted […]


FDA, Regulations

FDA starts pilot after AstraZeneca, J&J make case for novel drug delivery excipients

September 14, 2021

Via: FiercePharma

Academic literature features a steady stream of papers on novel excipients with the potential to improve drug delivery but they rarely show up in newly approved drugs because companies shy away from the additional risk they entail. Recognizing that, the […]


Manufacturing, Research and Development

AGC Biologics Expands pDNA and mRNA Manufacturing Capacity

September 14, 2021

Via: Contract Pharma

AGC Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO), unveiled expansion plans for the company’s Heidelberg facility to increase manufacturing capacities for plasmid-DNA (pDNA) and messenger RNA (mRNA) projects. With this expansion, AGC Biologics is boosting its current […]


Mergers and Acquisitions

Roche bets on T-cell therapies with Adaptimmune deal

September 8, 2021

Via: PMLiVE

The deal with see Adaptimmune receive $150m upfront, another $150m over the next five years and then milestone payments potentially exceeding $3bn in aggregate sales, as well as royalties. Unlike other leaders in next-generation cell therapies, the partners will use […]


Industry, Vaccines

Vaccine Study Explores COVID-19 and Autoimmune Disease

August 30, 2021

Via: Genetic Engineering and Biotechnology News

An estimated 8% of Americans have an autoimmune disease, including a disproportionate number of people in the minority communities most severely impacted by COVID-19. In addition, higher rates of severe COVID-19 and death have been reported in people with autoimmune […]


Industry, Vaccines

Contaminant in Moderna Vaccines in Japan Suspected to be Metallic Particles

August 27, 2021

Via: Biopharm International

On Aug.27, 2021, Japan suspended the use of 1.63 million doses of Moderna’s COVID-19 vaccine after a contaminant believed to be a metallic particle was found in the batch, according to a report from the Japanese Broadcasting Corporation. Japanese health […]


FDA, Regulations

FDA approves Lilly, Boehringer diabetes drug for heart failure

August 19, 2021

Via: Biopharma Dive

The expanded approval offers a significant boost for Jardiance, sales of which are already on track to top $1 billion this year. In the second quarter, revenue from the drug jumped 36% to about $357 million. Lilly and Boehringer next […]


News

White House rolls out COVID-19 booster plan, but the FDA and CDC have yet to have their say

August 18, 2021

Via: FiercePharma

Despite data showing two COVID-19 vaccine doses remain largely effective against severe symptoms, hospitalizations and deaths, the Biden administration is urging booster shots starting this fall to get a jump on the rise in infections among the vaccinated. The U.S. […]


Industry, Vaccines

FDA OK’s third dose of Moderna’s COVID-19 vaccine for immunocompromised

August 16, 2021

Via: Pharma Times

Specifically, the FDA has cleared a third booster dose for immunocompromised individuals aged 18 years or older, who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. “We […]


News

Merck’s Welireg becomes first drug for rare VHL tumours in US

August 16, 2021

Via: Pharmaphorum

The drug is part of Merck’s efforts to expand its oncology portfolio and reduce its reliance on big-selling cancer immunotherapy Keytruda (pembrolizumab), which is patent protected in the US and Europe until 2028. Welireg (belzutifan), an oral HIF-2 alpha inhibitor, […]


Pricing, Regulations

Biden Highlights Drug Pricing Reforms to Advance Legislative Agenda

August 13, 2021

Via: Biopharm International

The White House is looking to pay for some of its prime social and health initiatives by reducing outlays for prescription drugs, according to an announcement by President Biden that supports several leading drug-price control policies strongly backed by Democrats. […]