Drugs

The HIV vaccine candidate was developed using the same AdVac viral vector platform as the company’s COVID-19 vaccine. The Imbokodo study was run among young women in sub-Saharan Africa at high risk of acquiring HIV. The investigational adenovirus vector vaccine vaccine was found to have a favorable safety profile with no serious adverse events; but

“We now expect, particularly in the light of the need to produce vaccine booster shots and address the growth in variant forms, that this revenue will have a multi-year duration​,” said Thomas Castellano, senior vice president and CFO, Catalent, on a conference call yesterday with analysts, following the release of the CDMO’s fourth quarter 2021

CAMBRIDGE, Mass. & BEIJING, September 01, 2021–(BUSINESS WIRE)–BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that Brukinsa (zanubrutinib) has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). “We are delighted by

Operated by UPS and its subsidiary, UPS Flight Forward, the drones are delivering vaccines from Atrium Health Wake Forest Baptist Medical Center in Winston Salem to one of the health system’s family medicine practices located at Piedmont Plaza, around a one mile [1.6km] drive by car. When transporting the COVID-19 vaccines, the Matternet M2 drone

August 30, 2021 Audience: Health Professional, Pharmacy August 30, 2021 – Teligent Pharma, Inc. is voluntarily recalling one lot of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle to the user level. The product is being recalled because the firms testing has found it to be super potent based on an

Researchers at Brigham and Women’s Hospital, Massachusetts Institute of Technology and Novo Nordisk have revealed the new self-injecting capsule, called the liquid-injecting self-orienting millimeter-scale applicator (L-SOMA) that administers typically injected liquid medications orally. While injections help people who suffer from diseases such as Crohn’s disease, rheumatoid arthritis, and diabetes, these injections require training, equipment and are

ATLANTA, Aug. 30, 2021 /PRNewswire/ — UCB announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Briviact (brivaracetam) CV tablets, oral solution, and injection to treat partial-onset seizures in patients as young as one month of age.2 This is the first time that the IV formulation of Briviact

Construction of the facility is a key milestone and represents a critical next step in bringing effective and accessible CAR T therapies to cancer patients, as well as in how those therapies are produced, stored, and distributed, it said. Andy Scharenberg, cofounder and CEO, Umoja, said the facility will substantially enhance its vector manufacturing, process

BioNTech – which is developing mRNA vaccines against malaria and tuberculosis – says it intends to manufacture these vaccines on the African continent. A joint communiqué to this effect was published after a meeting of Uğur Şahin, CEO and Co-Founder of BioNTech, BioNTech with the kENUP Foundation, President Paul Kagame of Rwanda, President Macky Sall

The vaccine had previously been offered in the US under Emergency Use Authorization (EUA) since December; and has now become the first COVID-19 vaccine approved in the US. The approval is for people aged 16+, with use of the vaccine in adolescents aged 12-15 and the administration of a third booster shot in certain immunocompromised individuals

The inactivated whole virion vaccine, BBV87, has entered the randomized, controlled trial to evaluate the safety and immunogenicity of a two-dose regimen in healthy adults. The trial is starting at Clinica San Agustin in Costa Rica, and will expand next month to Panama and Colombia followed shortly afterwards by Thailand and Guatemala. Goals for an

For Pfizer and BioNTech’s Comirnaty, the CHMP has approved Delpharm’s Saint Rémy sur Avre site in France. The facility will manufacture finished product, and is set to provide around 51 million additional doses this year. A new manufacturing line at BioNTech’s Marburg manufacturing site has also been approved, increasing active substance manufacturing capacity by around

The alliance sees the UK headquartered Aptamer Group entering into an agreement with Sweden’s Bio-Works Technologies to co-develop a new affinity resin for improved purification and scale up of gene therapy vectors. Under the agreement, Aptamer will develop an Optimer ligand that is capable of binding and of eluting a viral vector. Bio-Works will then

Eurofarma will perform contract manufacturing activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network.   At full operational capacity, the annual production is expected to exceed 100 million finished doses annually of the shot, which this week became the first COVID-19 vaccine to receive full use approval from the US Food and Drug

The “strategic alliance”​ is designed to provide integrated, end-to-end distribution solutions for specialty cell and gene therapies that demand stringent temperature control, track and trace systems and global distribution.  “We face fragmented competition in Japan and globally. Cryoport is the clear market leader and is defining the industry standard,”​ commented Stefanovich. The partners expect to realize

Eurofarma will perform contract manufacturing activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network.   At full operational capacity, the annual production is expected to exceed 100 million finished doses annually of the shot, which this week became the first COVID-19 vaccine to receive full use approval from the US Food and Drug

Novartis and the trial teams will carry out a full evaluation of the BELINDA study data. “We were hopeful the BELINDA study would show that Kymriah could improve outcomes and the overall treatment experience for these patients in need. ​ “The study investigators will work together with Novartis in the coming weeks and months to

The Uppsala headquartered company supplies products for the purification of large-scale lipids, used in mRNA vaccine development and production. It claims that by enhancing production capacity of large-scale flash columns by 300%, it can support pharma companies and contract manufacturers’ scale up lipid production for COVID-19 vaccines. The bespoke production site is now operational in Cardiff.

Tibsovo is the first and only targeted therapy approved for patients with previously treated IDH1-mutated cholangiocarcinoma BOSTON, Aug. 25, 2021 /PRNewswire/ — Servier Pharmaceuticals, a growing leader in oncology committed to bringing the promise of tomorrow to the patients we serve, announced today that the U.S. Food and Drug Administration (FDA) approved Tibsovo® (ivosidenib tablets)

It will support the filling of liquid and lyophilized products. The installation is expected to be completed in 2022; the contract development and manufacturing organization (CDMO) said the investment would create more than 150 new positions at the Guangzhou site. The move sees drug product (DP) manufacturing capacity being established for clinical trial and commercial

FDA Approves Skytrofa (lonapegsomatropin-tcgd) for the Once-Weekly Treatment of Pediatric Growth Hormone Deficiency COPENHAGEN, Denmark, Aug. 25, 2021 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to potentially create new treatments that make a meaningful difference in patients’ lives, today announced that the U.S. Food and