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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Biotechnology
Merck & Co’s Keytruda (pembrolizumab) might have overtaken Opdivo (nivolumab) in the last quarter to become the top-selling cancer immunotherapy and has the most US approvals, but the Bristol-Myers Squibb drug is ahead in terms of approved indications in the European Union (EU). 31 July 2018
Biosimilars
One small step for biosimilars, one notable leap for Pfizer. 31 July 2018
Biotechnology
Novartis announced on Tuesday the approval of its game-changing migraine prevention therapy Aimovig (erenumab) by the European Medicines Agency (EMA). 31 July 2018
Generics
Last month, the Italian Antitrust Authority (ICA) closed the proceedings launched to verify South Africa-based Aspen Pharma’s (JSE: APN) compliance with its decision of September 2016, it was announced today. Aspen appealed the decision in October that year. 31 July 2018
Biotechnology
Sanofi and Regeneron intend to sidestep the pressures of the crowded PD-1 field by aiming for a first cemplimab approval in cutaneous squamous cell carcinoma (CSCC), which does not yet have any marketed checkpoint inhibitors, says life sciences analytics company GlobalData. 31 July 2018
Pharmaceutical
Danish CNS specialist Lundbeck and Japanese drugmaker Otsuka have announced the European Commission approval of Rxulti (brexpiprazole) for the treatment of schizophrenia in adults. 31 July 2018
Pharmaceutical
The Korean Ministry of Food and Drug Safety has approved the nausea therapy Akynzeo (netupitant/pelonosetron) for chemotherapy patients, said the drug's manufacturers on Tuesday. 31 July 2018
Pharmaceutical
Arizonian cannabinoid specialist INSYS Therapeutics suffered a near-10% drop in share price after announcing on Friday that the US regulator would not approve an application to market a buprenorphine sublingual spray it has been developing. 31 July 2018
Pharmaceutical
The US Food and Drug Administration’s acceptance of Merck KGaA’s (MRK: DE) resubmitted application for Mavenclad (cladribine), seven years after the original application, is seen as a positive in terms of the German drugmakers future in the multiple sclerosis therapy sector. 31 July 2018
Pharmaceutical
Both Russian and global pharmaceutical producers operating in the local market have called on the national government to ease the process of registration of drugs in Russia, reports The Pharma Letter’s local correspondent. 30 July 2018
Pharmaceutical
German drugmaker Merck KGaA, known as EMD in the USA and Canada, announced on Monday that its resubmission of Mavenclad (cladribine) has been accepted for review by the Food and Drug Administration (FDA). 30 July 2018
Pharmaceutical
Greg Hunt, Australian Minister for Health, released a statement on Monday confirming the addition of Novo Nordisk's Ryzodeg (insulin degludec/insulin aspart) and AbbVie's Maviret (glecaprevir/pibrentasvir) to the country's Pharmaceutical Benefits Scheme (PBS). 30 July 2018
Pharmaceutical
Well-publicized cases involving children needing cannabis-based treatments to reduce their suffering have led the UK to change its stance on these medicines for patients with an exceptional clinical need. 30 July 2018
Pharmaceutical
The US Food and Drug Administration has approved Perseris, the first once-monthly subcutaneous risperidone-containing, long-acting injectable (LAI) for the treatment of schizophrenia in adults. 30 July 2018
Biosimilars
Sandoz, a division of Swiss pharma titan Novartis, announced on Friday that it had received marketing authorization from the European Commission for its biosimilar equivalent of AbbVie's Humira (adalimumab). 30 July 2018
Pharmaceutical
From August 1, patients in New Zealand will have access to German pharma major Bayer’s oral anticoagulant Xarelto (rivaroxaban), used for preventing stroke and treating or preventing blood clots. 30 July 2018
Pharmaceutical
Last week saw the surprise announcement from Gilead Sciences that both its chief executive and chairman are to leave the company. On the M&A front last week, Sangamo Therapeutics decision to acquire the small French biotech TxCell featured. Regulatory news included a US Food and Drug Administration approval for Agios rare cancer treatment Tibsovo, while an FDA advisory panel voted against approval of GlaxoSmithKline’s Nucala for COPD. Also disappointing, was the latest data on Biogen and Eisai’s Alzheimer’s candidate BAN2401. 29 July 2018
Biosimilars
In what was clearly a bumper session for the regulator, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 16 medicines for approval at its July 2018 meeting. 28 July 2018
Pharmaceutical
At its July meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended a total of 16 medicines (see separate story for more), with the most significant developments being the following. 28 July 2018
Pharmaceutical
60 Degrees Pharmaceuticals (60P) announced today that the Antimicrobial Drugs Advisory Committee (AMDAC) of the US Food and Drug Administration voted to support tafenoquine, an investigational drug for the prevention of malaria in adults, voting (11 for; 2 against) on its efficacy and (9 for; 4 against) for its safety. 27 July 2018
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 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
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