A continued drive towards process efficiency and automation continues to spur the sector forward. But manufacturing demands for COVID-19 drugs and the rising demand for antibody-drug conjugates (ADCs) is also driving demand. Given the growing market, single-use systems will be in the spotlight at CPhI North America. Ever important: process efficiency The global single-use bioprocessing
Drugs
Treatment for Neutropenia Associated with Chemotherapy Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for Rolontis (eflapegrastim) HENDERSON, Nev.–(BUSINESS WIRE)–Aug. 6, 2021– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the
There are no preventive vaccines or effective treatments available for chikungunya. Valneva’s vaccine, which was recently awarded Breakthrough Designation status by the US Food and Drug Administration (FDA), expects final trial results in the next six months once the trial has completed a final analysis including 6 months of safety data. The candidate has also
Pharma event welcomes industry professionals ‘keen to meet’ Thanks to online conferencing technology, not even COVID-19 managed to bring in-person pharmaceutical gatherings to a complete stop. However, industry professionals are looking forward to getting together face to face again; the producers of CPhI North America are offering the option to gather in the real world
Combined with its new packaging plant in Columbus, Ohio (announced in June), Amgen is putting $1bn into additional manufacturing capacity to support predicted demand for its medicines in the coming years. Mixing traditional & next-gen technologies for optimum effect The new $550m plant in Holly Springs, North Carolina, will be located near the Raleigh-Durham area’s
With the launch of the clincial trial for mRNA-6231, the company’s mRNA-encoded IL-2 modified for the expansion of regulatory T cells, the company now has active clinic programs in five different therapeutic areas: infectious disease, oncology, cardiovascular, rare disease and autoimmune disease. mRNA‑6231 is a lipid nanoparticle (LNP)‑encapsulated mRNA-based therapeutic that encodes for mutein human interleukin 2,
Sanofi has partnered with Translate Bio since 2018 on mRNA vaccines; most recently with a COVID-19 vaccine candidate. Coming on the back of its announcement to build an mRNA Center of Excellence, Sanofi says the acquisition will help accelerate development of mRNA vaccines and therapeutics. Earlier this year, it also acquired Cambridge, Massachusetts mRNA biotech
Cell therapy showing promise in ALS trials: Coya Therapeutics For patients with amyotrophic lateral sclerosis (ALS), the prognosis is dire. According to National Institutes of Health statistics, most people succumb to the neurogenerative disease within three to five years of receiving the diagnosis—and while there are therapies that may help the symptoms, to date there
ganaxolone Treatment for CDKL5 Deficiency Disorder Marinus Pharmaceuticals Submits New Drug Application (NDA) to FDA for Ganaxolone for the Treatment of Seizures Associated with CDKL5 Deficiency Disorder and Provides Pipeline Update RADNOR, Pa.–(BUSINESS WIRE)–August 3, 2021 — Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders,
AstraZeneca has announced its drug Saphnelo (anifrolumab-fnia)—a first-in-class type I interferon receptor antibody—has landed approval by the US Food and Drug Administration (FDA). According to the pharmaceutical firm, the treatment is the first novel treatment for systemic lupus erythematosus (SLE) to receive the go-ahead from the agency in more than 10 years. The FDA reportedly
Treatment for Measles Prophylaxis, Mumps Prophylaxis, Rubella Prophylaxis GSK Files for Licensure of Priorix MMR Vaccine in the US August 2, 2021 — GSK today announced it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Priorix (Measles, Mumps, and Rubella Virus Vaccine, Live) and is seeking approval
FDA Approves Saphnelo (anifrolumab) for Moderate to Severe Systemic Lupus Erythematosus 2 August 2021 — AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.1 The approval by the Food and Drug Administration (FDA) was based on
BioNTech to develop mRNA malaria vaccine; unveils ambitions for Africa vaccine supply BioNTech wants to use the momentum behind its successful COVID-19 vaccine tech to apply it to other diseases. This week it announced it has set its sights on malaria: of which there were an estimated 229 million cases of worldwide in 2019, with an
TITUSVILLE, N.J. – July 30, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Uptravi (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO functional class (FC) II–III, who
That IPO, which took place on July 22, was priced at US$16 per share, with a pre-money valuation of about US$1.5bn. Yesterday afternoon [July 26], founder and CEO, Sean McClain, told us that those shares had reached US$23.88 each and the company was valued at US$2.15bn. The IPO, he continued, was a validation of both
Semglee is an insulin product indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Co-developed by Mylan [now Viatris] and Biocon Biologics, Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with its reference product Lantus (insulin glargine), said the US
tenapanor Treatment for Hyperphosphatemia of Renal Failure Ardelyx Receives Complete Response Letter from U.S. FDA for New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis FREMONT, Calif. and WALTHAM, Mass., July 29, 2021 /PRNewswire/ — Ardelyx Inc.,(Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class
We spoke to Prothena’s chief medical officer, Dr Hideki Garren, to hear more about both programs. When asked why the Ireland headquartered company went down the treatment and preventative route in its development of Alzheimer’s disease (AD) therapies, he told us: “Essentially we want to try and reach as many Alzheimer’s disease patients as possible.”
News FDA Alerts FDA Alerts Patients and Health Care Professionals About Clinical Trial Results Showing an Increased Risk of Death Associated with Pepaxto (melphalan flufenamide) July 28, 2021 Audience: Patients, Health Care Professionals July 28, 2021 — FDA is alerting patients and health care professionals that a clinical trial (OCEAN, Study OP-103) evaluating Pepaxto (melphalan
First authorized for emergency use in December, AstraZeneca’s viral vector vaccine has been plagued by concerns over rare incidents of blood clots since March. However, the main takeaway from the study’s authors is that the incidence rates of thrombosis is far higher in people who have been infected by COVID-19 than those who have received
29 July 2021 — GlaxoSmithKline plc (GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). This new indication for mepolizumab is for the add-on maintenance treatment of CRSwNP in adult
NORTH CHICAGO, Ill., July 29, 2021 /PRNewswire/ — Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion of Botox® to include eight new muscles for the treatment of upper limb spasticity in adults. The new muscles for treatment include additional muscles of the
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