Drugs

The contract development and manufacturing organization (CDMO) has been producing both the J&J and AstraZeneca vaccines, but mixed up ingredients from the two, causing the loss of 15 million doses, according to the New York Times. July 2020 saw Emergent sign off on a deal​​ with J&J for contract development and manufacturing services for its

The deal with iTheranostics, Inc, an affiliate of SOFIE Biosciences, Inc, sees the Swiss pharma giant acquiring compounds such as FAPI-46 and FAPI-74, among others. “Terms of the agreement are undisclosed but include upfront consideration along with milestone payments and royalties,”​ a spokesperson for Novartis told this publication.  The FAP assets in this deal were

FDA Approves Qelbree (viloxazine) for the Treatment of ADHD ROCKVILLE, Md., April 02, 2021 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) approved Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity

Earlier this year the companies had set the target of producing 2 billion doses in 2021, which it has now upped to 2.5 billion. “The increase is driven by the optimization of production processes, the recent initiation of production at BioNTech’s Marburg, Germany facility, regulatory approval for six dose vials, and the expansion of our

March 24, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy March 24, 2021 — FDA Safety Communication Purpose: To inform the public and healthcare providers that FDA has required and approved safety labeling changes to the Prescribing Information for Shingrix (Zoster Vaccine Recombinant, Adjuvanted) to include a new warning about the risk for Guillain-Barré Syndrome (GBS)

Basel, Switzerland based, Bright Peak, is a biotechnology company developing next generation immunotherapies for cancer and autoimmune disease. The deal sees it incorporate AJICAP, Ajinomoto Co.’s proprietary site-specific bioconjugation technology, for the development of Bright Peak immunocytokines. The companies outlined that there is potential for the combination of antibodies with Bright Peak’s cytokine derivatives conjugated

March 31, 2021 Audience: Patient, Health Professional, Pharmacy, Neurology, Cardiology, Psychiatry ISSUE: An FDA review of study findings showed a potential increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease who are taking the seizure and mental health medicine Lamictal (lamotrigine). FDA wants to evaluate whether other medicines in the same

On March 26, the US Food and Drug Administration (FDA) approved Abecma [idecabtagene vicleucel; ide-cel] as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for patients with relapsed or refractory multiple myeloma. The therapy is being jointly developed and commercialized in the US as part of a co-development, co-promotion, and

March 31, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy March 31, 2021 Weston, Florida – Apotex Corp is voluntarily recalling three (3) lots of Guanfacine Extended-Release Tablets 2mg to the consumer level due to trace amounts of Quetiapine Fumarate in one lot RX1663. Out of an abundance of caution, lots RX1662 and RX1664 are also included

Meanwhile, the first children were dosed last week in a global Phase 1/2/3 study to evaluate the safety, tolerability and immunogenicity of the vaccine in children aged 6 months to 11 years old. In the US (and many other jurisdictions), the vaccine is currently authorized for people aged 16+, although vaccination campaigns have prioritised older

PARIS, March 31, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. “In the Phase 3 IKEMA study, the addition

GSK will provide fill and finish manufacturing capacity at the facility in the North East of England. Promising a rapid technology transfer between the two companies, beginning immediately, GSK hopes to be in a position to start manufacture of NXV-CoV2373 at the beginning of May.   Meanwhile, the protein antigen component of the vaccine is also being produced in

News FDA Alerts Namoo Enterprise LLC Issues Voluntary Nationwide Recall of PremierZen Black 5000 Due to the Presence of Undeclared Sildenafil and Tadalafil March 26, 2021 Audience: Consumer March 26, 2021 — Little Ferry, NJ, Namoo Enterprise LLC is voluntarily recalling all lots within expiry of PremierZen Black 5000 capsules to the consumer level. FDA

COVID-19 vaccines ‘induce robust immune response’ in pregnant women: study Pregnant women have been excluded from large vaccine trials to date, and yet this group is more likely to become severely ill with COVID-19 and may be at increased risk for adverse pregnancy outcomes, according to the US Centers for Disease Control and Prevention.  The

FDA Approves Roszet (rosuvastatin and ezetimibe) to Reduce LDL-C in Hyperlipidemia and Homozygous Familial Hypercholesterolemia Morristown, N.J. March 31, 2021 — Althera Pharmaceuticals, a company focused on heart health, today announced the FDA approval of Roszet (rosuvastatin and ezetimibe) tablets, as an adjunct to diet, for treatment of elevated low-density lipoprotein cholesterol (LDL-C) in adult

DUBLIN, March 30, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved a revised label for Vyxeos® (daunorubicin and cytarabine) to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients aged one year and older. The approval of Vyxeos for this indication

The US regulator issued a Complete Response Letter (CRL) to MSD for its supplemental Biologics License Application (sBLA) for Keytruda or pembrolizumab in high-risk early-stage triple negative breast cancer (TNBC).  The sBLA sought backing for MSD’s checkpoint inhibitor, Keytruda, for TNBC patients in combination with chemotherapy as pre-operative treatment and then as a single agent

March 25, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy March 25, 2021 — Pennington, NJ, Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, to the Hospital/User level after receiving several complaints of crystallization in vials. Administration of crystalized Acyclovir Sodium Injection, 50

The scientific opinion from the EMA’s human medicines committee (CHMP) – as per Under Article 5 (3) of Regulation 726/2004 – can be considered by EU member states when making decisions on the possible use of monoclonal antibody therapies at a national level prior to a marketing authorization. Regdanvimab is a monoclonal antibody, a type