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
The US Drug Enforcement Administration (DEA) has given the nod for GW Pharmaceuticals to retail its cannabis-based therapy Epidiolex (cannabidiol), just three months after it was approved by the US regulator. 28 September 2018
Pharmaceutical
The US Congress has agreed on a wide-ranging bill aimed at tackling the burgeoning epidemic of opioids abuse in the country, while rejecting a pharma industry amendment that would have reduced drugmakers' share of medicine costs under Medicare. 27 September 2018
Pharmaceutical
A mandated price drop is about to come into effect in Australia on 226 medicine brands listed on the Pharmaceutical Benefits Scheme (PBS). 27 September 2018
Biosimilars
The worth of the global biosimilars market will have risen from its $4.36 billion 2016 value by 34% at compound annual growth rate to nearly $20 billion by 2025, a study has predicted. 27 September 2018
Pharmaceutical
The world’s largest healthcare plan has been launched by Indian Prime Minister Narendra Modi, providing free or subsidized coverage for the poorest 40% of India’s population. 27 September 2018
Biotechnology
Regulators and representatives from the UK biopharma industry met for the eighth annual joint conference in London, aimed at promoting the successful development of the sector. 27 September 2018
Biotechnology
Adding to a busy news week for Gilead Sciences, a court in Brazil has announced it will strip the Californian firm of its exclusivity patent for Sovaldi (sofosbuvir), at the request of presidential candidate Rolando Valcir Spanholo. 26 September 2018
Biotechnology
The USA’s Institute for Clinical and Economic Review (ICER) has released a Draft Evidence Report assessing the clinical effectiveness and value of biologic treatments for asthma associated with Type 2 inflammation and/or allergic asthma. The draft report will be open to public comment until October 22, 2018. 26 September 2018
Biotechnology
The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing approval for Blincyto (blinatumomab) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). 26 September 2018
Biosimilars
The European Medicines Agency has approved Pelgraz (pegfilgrastim) and in some countries it could be in the hands of healthcare professionals this week, making it the first biosimilar of Amgen’s (Nasdaq: AMGN) Neulasta to reach patients in Europe. 26 September 2018
Pharmaceutical
The US Food and Drug Administration has said that the partial clinical trial hold it imposed on East Coast-USA based Epizyme in August will be lifted. 25 September 2018
Generics
With mounting legal challenges to its hepatitis C patent estate abroad, and rising competition at home, California’s Gilead Sciences has decided to get ahead of the game and launch its own approved generics for Epclusa (sofosbuvir/velpatasvir) and Harvoni (ledipasvir/sofosbuvir). 25 September 2018
Biotechnology
There was good news yesterday for Massachusetts, USA-based cancer specialist Verastem Oncology, vindicating the company’s faith in an in-licensed blood cancer drug that a former partner had ditched. 25 September 2018
Pharmaceutical
The recently elected Morrison Australian government today said it will invest A$52 million ($38 million) to protect the nation’s teenagers against meningococcal disease, with the launch of a new free national program for 14 to 19 year olds. 25 September 2018
Pharmaceutical
Last year’s $1.7 billion takeover of US oncology firm Ignyta is beginning to look like it will pay off for Roche, after the Swiss giant announced plans to file for regulatory approval for key pipeline acquisition entrectinib. 25 September 2018
Generics
The US Food and Drug Administration yesterday published notice of the final guidance for industry Abbreviated New Drug Application submissions (ANDA). 25 September 2018
Biotechnology
The European Commission has granted marketing authorization for Imfinzi (durvalumab) as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumors express PD-L1 on ≥1% of tumor cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). 24 September 2018
Pharmaceutical
Hot on the heels of its approval in Europe, the Australian Therapeutic Goods Administration (TGA) has given the green light to Ilumya (tildrakizumab) for moderate-to-severe plaque psoriasis patients who are candidates for systemic therapy. 24 September 2018
Biotechnology
A High Court case win by 12 National Health Service (NHS) Clinical Commissioning Groups (CCGs) in favor of prescribing the significantly cheaper anti-vascular endothelial growth factor (anti-VEGF), Avastin (bevacizumab), over Novartis’ (NOVN: VX) and Bayer’s (BAYN: DE) licensed anti-VEGF eye drugs has import implications, says analyst. 24 September 2018
Pharmaceutical
The European Medicines Agency has revised the number of centrally authorized medicines (CAPs) for which, based on current knowledge, there are concerns of Brexit-related supply disruptions from 108 to 39. 24 September 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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