Regulation
Refine Search
Pharmaceutical
Shanghai-based Dizal has made a submission to the US Food and Drug Administration, seeking approval for sunvozertinib. 8 November 2024
Biotechnology
US mRNA specialist Moderna today announced Health Canada has approved mRESVIA (respiratory syncytial virus mRNA vaccine) for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. 8 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
Asklepios BioPharmaceutical (AskBio) today announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug designation from the US Food and Drug Administration (FDA) for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 7 November 2024
Pharmaceutical
USA-based Acadia Pharmaceuticals has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million upon the closing of the transaction. 6 November 2024
Biotechnology
GSK’s Arexvy (RSV vaccine) has received an expanded approval in Canada to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50-59 who are at increased risk. 6 November 2024
Biotechnology
French pharma major Sanofi’s Dupixent (dupilumab), which notched up sales of 3.5 billion euros ($3.8 billion) in third-quarter 2024, +23.8% year-on-year, has picked up yet another indication in collaboration with Regeneron. 6 November 2024
article
The US Food and Drug Administration (FDA) has announced approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) 6 November 2024
Pharmaceutical
European regulators will decide by December 6 whether Novo Holdings, the controlling shareholder of Danish pharma giant Novo Nordisk, can finalize its $16.5 billion acquisition of contract drug manufacturer Catalent. 5 November 2024
Pharmaceutical
Photocure, a Norway-based bladder cancer-focused company, has announced that Jiangsu Yahong Meditech, the parent company of its partner Asieris Pharmaceuticals, has received marketing authorization for Hexvix (hexaminolevulinate) in China. 5 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older, under development by Ionis Pharmaceuticals. 4 November 2024
Pharmaceutical
Disc Medicine today announced a successful End of Phase 2 with the US Food and Drug Administration (FDA) supporting the regulatory path forward, including potential for accelerated approval, for bitopertin in erythropoietic protoporphyria (EPP). 4 November 2024
Pharmaceutical
On Friday, the US Food and Drug Administration published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub,” by Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER) and Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER). 4 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted a Rare Pediatric disease designation for BPM31510T, an investigational treatment for epidermolysis (EB) from BPGbio. 4 November 2024
Pharmaceutical
US pharma major AbbVie last week proposed $1.4 billion acquisition of US CNS drug developer Aliada Therapeutics. Last week saw a bunch of third quarter 2024 financials results, among which were Elil Lilly, AbbVie and Merck & Co. Also of note, Lexicon’s type I diabetes drug Zynquista faced a Food and Drug Administration (FDA) advisory committee review that resulted in largely negative vote against recommendation. 3 November 2024
Pharmaceutical
Texas-based biopharma Lexicon Pharmaceuticals was trading nearly 36% lower on Friday morning. 1 November 2024
Generics
Medicines for Europe has launched a study of market barriers faced by European generics and biosimilar pharmaceutical companies operating in 11 key third-country markets. 31 October 2024
Biotechnology
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine sugemalimab (trade name Eqjubi) to treat adult patients with a type of cancer called non-small cell lung cancer (NSCLC ). 31 October 2024
Pharmaceutical
Novartis late yesterday revealed that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). 30 October 2024
Pharmaceutical
Privately-held US drugmaker Protega Pharmaceuticals says that the US Food and Drug Administration (FDA) has approved Roxybond (oxycodone hydrochloride) immediate-release (IR) CII 10mg tablet for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 29 October 2024
Biotechnology
India's first mRNA-based Omicron-specific COVID-19 booster shot from Gennova Biopharmaceuticals, a needle-free vaccine, is under scrutiny by the subject experts' committee (SEC) under the drug regulatory authority 18 April 2023
Biotechnology
The European Commission (EC) has approved Rinvoq (upadacitinib) as the first oral Janus Kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. 18 April 2023
Pharmaceutical
Research from industry analyst GlobalData highlights the significance of the pediatric treatment opportunity for Novartis’ Entresto (sacubitril/valsartan). 18 April 2023
Biotechnology
The US Food and Drug Administration yesterday approved Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery of neutrophils (a subset of white blood cells) in the body and reduce the risk of infection. 18 April 2023
Pharmaceutical
The Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee of the US Food and Drug Administration’s (FDA) on Friday discussed supplemental New Drug Application (sNDA) of Rexulti (brexpiprazole) for the treatment of agitation associated with Alzheimer’s dementia (AAD). 17 April 2023
Generics
In 2022, 91% of prescriptions in the USA were filled by generic drugs, which in turn accounted for only 18.2% of the country’s pharmaceutical spending.1 17 April 2023
Biotechnology
Significant research news last week included US firm Horizon Therapeutics reporting positive Phase IV data on its thyroid eye disease medication Tepezza, while mRNA specialist Moderna released an ambivalent analysis of its influenza vaccine program. Also, French biotech Genfit announced important developments in its R&D pipeline, notably on elafibranor in cholangitis and non-alcoholic steatohepatitis (NASH), and on ezurpimtrostat. On the regulatory front, Germany’s Merck KGaA had a setback with its multiple sclerosis candidate evobrutinib last week, when the US Food and Drug Administration (FDA) slapped a partial clinical hold on its Phase II trial. 16 April 2023
Pharmaceutical
The Indian government has taken strict action against 34 companies in what is being termed the biggest crackdown against pharmaceutical companies manufacturing substandard drugs. Licenses of 18 pharma companies have been cancelled, in what would serve as a clear warning to erring pharmaceutical companies. 14 April 2023
Pharmaceutical
The next legal battleground for the abortion pill mifepristone will be in the US Supreme Court. 14 April 2023
Biotechnology
An important regulatory submission from Eli Lilly has not been successful, with the US regulator issuing a complete response letter (CRL) for mirikizumab in ulcerative colitis. 14 April 2023
Pharmaceutical
Amid an ongoing epidemic of opioid abuse in the USA, the country’s medicines regulator has announced safety label changes for opioids aimed at ensuring their safe use. 14 April 2023
Biosimilars
A lot of topics were discussed at the 2023 China innovative medicine (device) medical conference (CMAC) held in Suzhou on April 7. Among them were real world studies, medical affairs and how to use AI to speed up discoveries. But one most talked about was the challenges for Chinese biotechs to go global. 13 April 2023
Biotechnology
Sino-American biotech BeiGene today announced the first major step in the company’s expansion in Latin America (LATAM) with the formal opening of its office in São Paulo, Brazil. 13 April 2023
Biotechnology
A draft evidence report from Boston, USA-based watchdog The Institute for Clinical and Economic Review (ICER) suggests a cost-effective price of up to $1.9 million for new sickle cell disease (SCD) therapies. 13 April 2023
Pharmaceutical
The US Biotechnology Innovation Organization (BIO) has signed onto an amicus brief to challenge a District Court’s unprecedented ruling (related to the ‘morning after’ abortion pill mifepristone (marketed under the trade name Mifeprex) that would create regulatory barriers and potentially upend the US Food and Drug Administration’s (FDA) authority to approve life-saving and life-enhancing therapies to patients. 13 April 2023
Biotechnology
Moderna and Merck & Co have announced that mRNA-4157/V940 alongside Keytruda (pembrolizumab) has been granted Priority Medicines (PRIME) scheme designation by the European Medicines Agency (EMA) for the adjuvant treatment of high-risk stage III/IV melanoma following complete resection. 11 April 2023
Pharmaceutical
Pharma manufacturers will be challenged by the effects of high inflation and declining US Food and Drug Administration (FDA) drug approvals in 2023. 11 April 2023
Pharmaceutical
A Texas federal judge on Friday ruled that the US Food and Drug Administration (FDA) "stonewalled judicial review" of its decades-old approval of the ‘morning after’ abortion pill mifepristone (marketed by Danco Laboratories under the trade name Mifeprex) and agreed to stay the effective date of the drug's approval. 11 April 2023
Biotechnology
Regulatory news last week featured the combination of Padcev and Keytruda, developed by US biotech Seagen and Japan’s Astellas Pharma, gaining accelerated approval from the US Food and Drug Administration (FDA) for the treatment of urothelial cancer. Also, Germany’s InflaRx gained emergency use authorization (EUA) for its COVID-19 treatment Gohibic (vilobelimab). On the research front, US biotech OncoSec Medical had a major setback last week, when it reported that its TAVO-EP, in combination with Merck & Co’s mega-blockbuster immune-oncology drug Keytruda, missed the endpoint of a Phase II study in melanoma. With better news, UK pharma major AstraZeneca announced positive results from the DUO-O Phase III trial of Lynparza in combination with Imfinzi for the treatment of ovarian cancer. 9 April 2023
Pharmaceutical
The US Food and Drug Administration announced the final decision to withdraw approval of Makena (hydroxyprogesterone caproate injection) - a drug that had been approved under the accelerated approval pathway and marketed by privately-held Swiss drugmaker Covis Pharma. 7 April 2023
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze