Pharma & Biotech Pricing, Policy & Regulation
Pharmaceutical
In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
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Pharmaceutical
Privately-owned German pharma Boehringer Ingelheim’s Praxbind (idarucizumab) has been added to the UK’s national antidote list. 31 March 2017
Pharmaceutical
There's no doubt about it - last week's failure to pass the American Health Care Act was a painful setback in the fight to repeal and replace Obamacare, wrote Sally Pipes in the Washington Examiner’s Beltway Confidential blog. 31 March 2017
Generics
Research has shown that imports of generic drugs to the USA have fallen since President Trump was elected and took office. 31 March 2017
Pharmaceutical
The US Food and Drug Administration (FDA) has fully approved AstraZeneca’s non-small cell lung cancer (NSCLC) treatment Tagrisso (osimertinib), the company announced today. 31 March 2017
Pharmaceutical
Canada-based Aeterna Zentaris’ announced that, following its meeting with the US Food and Drug Administration on March 29, 2017, the company intends to file a New Drug Application (NDA) seeking approval of Macrilen (macimorelin) for the evaluation of growth hormone deficiency in adults (AGHD). 30 March 2017
Pharmaceutical
President Trump's choice to head up the US Food and Drug Administration, Scott Gottlieb, is severing ties with industry in an attempt to put clear blue water between his previous life as a pharmaceutical insider and his new incarnation as FDA Commissioner. 30 March 2017
Pharmaceutical
UK-based Mundipharma has received the green light from Japanese regulators to market Mundesine (forodesine hydrochloride), the first regulatory approval for the novel therapy. 30 March 2017
Biosimilars
International expansion and bringing affordable biosimilars to patients are two of the stated aims of privately-held Russian biotech company Biocad, and the company has taken a step forward on both fronts with news on one of its products. 30 March 2017
Biotechnology
The Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously (11 to 0) that the benefit-risk of rituximab/hyaluronidase for subcutaneous injection was favorable for the treatment of certain blood cancers. 30 March 2017
Biotechnology
The US Food and Drug Administration has accepted the Biologics License Application (BLA) filing and granted priority review for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). 30 March 2017
Generics
News that the company had received a complete response letter (CRL) from the US Food and Drug Administration (FDA) on its abbreviated new drug application (ANDA) for a generic version of a big-selling asthma medication caused a 3% drop in the share price of Mylan on Wednesday. 30 March 2017
Pharmaceutical
Before Theresa May signed the decree absolute, Ireland began preparing its bid to become the new home of the European Medicines Agency (EMA). 29 March 2017
Biotechnology
Steve Bates, the chief executive of UK trade group The BioIndustry Association (BIA), spoke of his opposition to the UK leaving the European Union (EU) prior to last year’s referendum, saying it would be damaging for the biopharma industry. 29 March 2017
Pharmaceutical
US specialty pharma company Acorda Therapeutics has released positive results from two ongoing, long-term safety studies of CVT-301 in people with Parkinson’s disease. 29 March 2017
Biotechnology
The US Food and Drug Administration (FDA) has approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). 29 March 2017
Biotechnology
US pharma giant Pfizer has received marketing authorization from the European Commission for its Xeljanz (tofacitinib citrate) 5mg twice daily oral tablets in combination with methotrexate (MTX) for moderate to severe active rheumatoid arthritis (RA) in adults who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs. 29 March 2017
Biotechnology
The US Food and Drug Administration has approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). 29 March 2017
Pharmaceutical
The US Food and Drug Administration has accepted the New Drug Application (NDA) for Lynparza (olaparib) tablets (300mg twice daily) for use in platinum-sensitive, relapsed ovarian cancer patients in the maintenance setting. 29 March 2017
Pharmaceutical
NDA Group announced findings from its fourth annual comparison of drug approvals in the European Union and the USA, ahead of this year’s DIA EuroMeeting in Glasgow, Scotland. 29 March 2017
Pharmaceutical
Eagle Pharmaceuticals has announced the US Food and Drug Administration will review its filing for Ryanodex (dantrolene sodium), and has given the therapy priority review designation. 29 March 2017
Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Biotechnology
China’s Innovent Biologics has announced that the updated 2024 National Reimbursement Drug List (NRDL) now includes Sintbilo (tafolecimab) injection, an anti-PCSK9 monoclonal antibody for the first time. The updated NRDL will be officially effective from January 1, 2025. 29 November 2024
Pharmaceutical
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Pharmaceutical
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
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