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
Seattle Genetics has been given Breakthrough Designation from the US Food and Drug Administration for Adcetris (brentuximab vedotin) for certain peripheral T-cell lymphomas (PTCL). 16 November 2018
Pharmaceutical
The European Commission yesterday released the results of a new Eurobarometer study on the public knowledge on antibiotics and overall trends in their use ahead of the 11th European Antibiotic Awareness Day. 16 November 2018
Generics
Glenmark Pharmaceuticals has been granted final approval by the US Food and Drug Administration for teriflunomide tablets, 7mg and 14mg, a generic version of French pharma major Sanofi’s multiple sclerosis drug Aubagio. 16 November 2018
Biotechnology
The UK’s National Health Service (NHS) will pay for eligible English children and young people with pediatric acute lymphoblastic lymphoma (ALL) to be treated with Novartis’ CAR-T therapy Kymriah (tisagenlecleucel). 16 November 2018
Pharmaceutical
The British pharmaceutical industry has welcomed a draft proposal, agreed by UK and European Union negotiators, detailing terms for a phased withdrawal from the EU. 16 November 2018
Biosimilars
After a number of setbacks on the path to market, US pharma giant Pfizer has announced the introduction of Retacrit (epoetin alfa-epbx) injection in the USA. 15 November 2018
Pharmaceutical
As Indians are at a higher risk of rare genetic diseases, the Indian government in May last year put in place a National Rare Disease Policy, allocating $12.86 million towards genetic disorders. However, implementation of this policy has yet to see the light of the day, with experts raising concerns over the long delay, reports The Pharma Letter’s India correspondent. 15 November 2018
Biotechnology
Despite the market’s earlier optimism, the wild ride for investors in Samsung BioLogics continued on Wednesday, after South Korea’s financial watchdog found that the firm had intentionally broken accounting rules. 15 November 2018
Biotechnology
Eli Lilly’s 25 years spent researching headache disorders looks a little closer to paying off after a couple of announcements. 15 November 2018
Pharmaceutical
One of the USA’s largest insurers has pointed to the increase in the cost of branded medicines as a key reason for US healthcare costs going up even as generics grab a greater share of the market. 15 November 2018
Pharmaceutical
The US Food and Drug Administration's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 10 to 7 to approve the SpecGx investigative abuse-deterrent formulation of immediate-release, single-entity oxycodone tablets for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 15 November 2018
Biotechnology
A report from the Institute for Clinical and Economic Review (ICER) finds that a group of new asthma drugs are priced at twice the price that they should be to deliver value for money. 14 November 2018
Pharmaceutical
The European Medicines Agency has published the new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the pediatric population. 14 November 2018
Pharmaceutical
The USA’s leading pharmacy benefit manager (PBM) has announced that it is introducing a new formulary to provide employers and health plans a better opportunity to leverage changing dynamics to help lower their members' out-of-pocket costs. 14 November 2018
Pharmaceutical
The US Food and Drug Administration yesterday proposed amending its regulations to implement a provision of the 21st Century Cures Act and add an exception to informed consent requirements for certain FDA-regulated clinical investigations that present no more than minimal risk to human research participants. 14 November 2018
Biotechnology
Shares in Samsung BioLogics climbed 9% on Tuesday, as concerns over the firm being delisted due to accounting irregularities appeared to subside. 13 November 2018
Pharmaceutical
Rare disease specialist Shire has filed to extend the label for Gattex (teduglutide) in the USA to include pediatric patients with short bowel syndrome (SBS) who are dependent on parenteral support. 13 November 2018
Biotechnology
California, USA-based Modis Therapeutics announced today that the European Medicines Agency has granted PRIME (PRIority MEdicines) designation to MT1621, Modis' investigational treatment for patients with thymidine kinase 2 deficiency (TK2d). 13 November 2018
Pharmaceutical
Findings presented by Japan’s largest drugmaker Takeda at ISPOR 2018 report that where standards of care are not clearly defined in terms of cost or outcomes, the ability of payers to accurately estimate the cost effectiveness of new therapeutic options can be hindered. 13 November 2018
Biotechnology
The stand-off between Vertex Pharmaceuticals and the UK’s cost watchdog for medicines over the cystic fibrosis (CF) drug Orkambi (lumacaftor/ivacaftor) has now gone on for two-and-a-half years. 12 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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