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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Generics
R-Pharm plans to dominate in public procurements of anti-HIV and hepatitis drugs in Russia, the overall annual value of which is estimated at 20 billion roubles (~$300 million), according to recent statements of some senior officials of the Russian Ministry of Health and sources of the company, The Pharma Letter’s local correspondent reports. 22 November 2018
Pharmaceutical
Swedish drugmaker Camurus (STO: CAMX) today said that the European Commission has granted marketing authorization for Buvidal (CAM2038), with news of the approval sending the firm’s shares soaring 9.38% to 89.80 Swedish kronor. 22 November 2018
Pharmaceutical
The US Food and Drug Administration Wednesday approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML). 22 November 2018
Generics
The 2nd Value Added Medicines conference, which took place in Brussels, Belgium, yesterday, gathered a wide range of experts in the healthcare community to raise awareness, informed debate with the mutual intention to present solutions for maximizing the benefits of and encouraging the development of continuous innovation. 22 November 2018
Biotechnology
British cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) that recommends inclusion of Keytruda (pembrolizumab) in the Cancer Drugs Fund (CDF) in lung cancer. 22 November 2018
Pharmaceutical
New, draconian measures aimed at lowering drug prices by preventing drug companies from exceeding certain price thresholds have been proposed in the US Senate. 21 November 2018
Pharmaceutical
Shares in Novartis ticked downwards on Tuesday after the US Food and Drug Administration revealed it was adding a new warning to the label for the firm’s multiple sclerosis (MS) medicine Gilenya (fingolimod). 21 November 2018
Biotechnology
Weeks after a US Food and Drug Administration (FDA) panel overwhelmingly voted in support of the benefit-risk profile of Sage Therapeutics’ Zulresso (brexanolone) in postpartum depression (PPD), the agency has delayed a decision on whether to approve it. 21 November 2018
Biotechnology
The US Food and Drug Administration has granted the Biological Product Designation for Israel-based biotech BioLineRx’ novel immunotherapy compound AGI-134. 21 November 2018
Biotechnology
The US Food and Drug Administration (FDA) has approved Gamifant (emapalumab-lzsg), an interferon gamma (IFNγ) blocking antibody, in an ultra-rare syndrome of hyperinflammation with high morbidity and mortality and for which there was previously no drug on the market. 20 November 2018
Biotechnology
As expected, following a positive recommendation from its advisory panel in September, the European Medicines Agency has granted approval for Emgality (galcanezumab), in the treatment of migraines. 19 November 2018
Biotechnology
The China National Medical Products Administration (NMPA) has approved Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for chronic hepatitis B in adults and adolescents (aged 12 years and older with body weight at least 35kg). 19 November 2018
Biotechnology
Admitting that its trial results are not strong enough, Roche has told the European Medicines Agency (EMA) not to consider a type II variation to extend the use of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab). 19 November 2018
Pharmaceutical
Promacta (eltrombopag), a drug from Swiss pharma giant Novartis that is marketed as Revolade in most countries outside the USA, has had its label expanded by the US Food and Drug Administration (FDA). 19 November 2018
Biotechnology
Influential cost-effectiveness watchdog ICER - the Institute for Clinical and Economic Review - has found that three therapies for the ultra-rare and potentially fatal disorder hereditary angioedema (HAE) are not cost-effective. 19 November 2018
Biosimilars
South Korean drugmaker Celltrion Healthcare outlined its vision of ‘shaping future healthcare by improving access to biosimilars’ at the 5th Annual Biosimilars USA Conference in New Jersey, USA. 19 November 2018
Pharmaceutical
Earlier this month, the leading Russian professional associations in the pharmaceutical industry and communication services market, in the presence of Federal Antimonopoly Service (FAS) Russia, signed the “Recommendations on compliance with legislation on advertising of non-prescription medicines” in Moscow. It was developed in close cooperation with FAS Russia. 19 November 2018
Pharmaceutical
The US Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by non-invasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool. 17 November 2018
Pharmaceutical
Shares in Seattle Genetics are up nearly 5% and climbing today after the firm announced a new approval for Adcetris (brentuximab vedotin), shortly after revealing the US regulator had granted the therapy Breakthrough Designation in the same indication. 16 November 2018
Pharmaceutical
The European Medicines Agency’s Committee for Products for Human Use (CHMP) recommended four medicines for approval, including one for use in countries outside the European Union, at its November 2018 meeting, as well as two re-examinations and four indication extensions. 16 November 2018
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 BeOne Medicines, formerly 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
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
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
Pharmaceutical
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. 25 November 2024
Pharmaceutical
Efforts to combat antimicrobial resistance (AMR) are gaining momentum in Europe, with the introduction of innovative measures to drive the development of new antimicrobials. 25 November 2024
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
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