Pricing, reimbursement and access
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Biotechnology
UK and USA-based biotech firm Orchard Therapeutics’ shares closed up 7.6% and rose a further 4.4% to $1.18 in after-hours trading on Friday, after the company gained clearance for Nation Health Service use in England and Wales for its stem cell therapy Libmeldy (atidarsagene autotemcel). 5 February 2022
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has recommended that Jardiance (empagliflozin), from German family-owned pharma major Boehringer Ingelheim and marketed in partnership with Eli Lilly, will be recommended as a clinical and cost-effective treatment option for adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF) as an add-on to optimized standard care. 4 February 2022
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending Opdivo (nivolumab) plus Yervoy (ipilimumab) for patients with previously untreated advanced renal cell carcinoma (RCC) that is intermediate- or poor-risk, US pharma major Bristol Myers Squibb has revealed. 4 February 2022
Pharmaceutical
Pharma trade group Medicines Australia is calling for the new National Medicines Policy (NMP) to be pushed back until after the federal election, expected in May. 4 February 2022
Generics
UK-based Alliance Pharma (AIM: APH) saw its shares close down 6.9% at 105.54 pence today, after it provided an update on the Competition and Markets Authority (CMA) investigation first announced in May 2019 in which four companies, including Alliance, have been subject to a lengthy investigation. 3 February 2022
Pharmaceutical
Trade group Medicines Australia has called for the country’s government to deliver a plan that shortens the time that patients wait for access to the latest innovative treatments and vaccines. 28 January 2022
Biotechnology
US FDA approval may have felt like the finishing line, but a long and winding road to reimbursement still stretches ahead for Aduhelm (aducanumab). 28 January 2022
Generics
Texas, USA-based Mark Cuban Cost Plus Drug Company (MCCPDC) officially launched its online pharmacy yesterday. The launch comes just weeks after its pharmacy benefit manager (PBM) operation was established - both critical efforts in the company's pursuit to help shield consumers from inflated drug prices. 28 January 2022
Biotechnology
Checkpoint Therapeutics has announced positive topline results from its registration-enabling clinical trial of the novel checkpoint blocker cosibelimab. 25 January 2022
Biosimilars
Hailing the benefits of 15 years of biosimilar prescribing in Europe, The Biosimilar Medicines Group has called on the European Medicines Agency to take stronger action to widen access to this type of medicine. 25 January 2022
Generics
Generic medicines in India have received a new impetus with both Prime Minister Narendra Modi and Venkaiah Naidu, Vice President of India, calling on the domestic pharmaceutical industry to work towards making India an international capital of generic drugs. 24 January 2022
Biosimilars
The ongoing review of the European pharmaceutical legislation framework is a major opportunity to update the regulatory system in the European Union, says Medicines for Europe, which represents the generics and biosimilars drugmakers. 24 January 2022
Pharmaceutical
The British pricing and reimbursement agency has updated its guidance for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate), broadening access to the therapy. 24 January 2022
Pharmaceutical
Thousands of Hungarian patients may have better life prospects after a decision was made again to include new therapies to the social security subsidy system following a two-year pause. As a result, 31 new medicines or indications will now be available under regular subsidy thanks to a regulation published at the end of December. 24 January 2022
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has published its conclusions to its review of its methods and processes for health technology assessments, which has received a mixed reaction form the biopharma industry. 21 January 2022
Pharmaceutical
The equity research team at US financial services firm Morningstar has published the Annual Drug Pipeline report, which looks at the large-cap biopharma groups and their position in the market. 20 January 2022
Biosimilars
Biosimilars focussed Icelandic company Alvotech Holdings and Oaktree Acquisition Corp. II (Oaktree II), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, today announced $21 million in additional commitments for a private placement (PIPE) of Oaktree II common stock in connection with their proposed business combination. 19 January 2022
Biotechnology
USA-based EQRx (Nasdaq: EQRX), which launched in January 2020 with the aim of creating patent-protected medicines at dramatically lower prices, along with its China-based partner CStone Pharmaceuticals (HKEX: 2616), yesterday announced that sugemalimab plus chemotherapy demonstrated a statistically-significant improvement in overall survival (OS) compared to placebo plus chemotherapy as a first-line treatment for patients with Stage IV non-small cell lung cancer (NSCLC) in the randomized, double-blind Phase III GEMSTONE-302 study. 19 January 2022
Pharmaceutical
As the UK’s National Institute for Health and Care Excellence (NICE) looks set to approve changes to the way it evaluates new medicines and health technologies, the Association of the British Pharmaceutical Industry believes that – taken in their entirety - the changes will move the needle in the right direction for NHS patients. 19 January 2022
Biotechnology
Among last week’s notable announcements, US pharma giant Pfizer said it has entered into a gene base editing collaboration with Beam Therapeutics, which involves an upfront $300 million and up to $1.35 billion in milestones. Germany’s Bayer moved further into cell and gene therapies, announcing a $1 billion deal with Mammoth Biosciences. US biotech Biogen and Japanese partner Eisai took a hit last Tuesday, when the US federal insurer, Medicare, announced restrictions on the availability of their controversially approved Alzheimer’s treatment Aduhelm. Also, US drugmaker Vertex Pharmaceuticals gained an additional approval for its cystic fibrosis drug Kaftrio from the European Commission. 16 January 2022
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 November 2024
Pharmaceutical
Johnson & Johnson has taken legal action to defend a contentious rebate initiative, filing a lawsuit in the US District Court for the District of Columbia. 15 November 2024
Biotechnology
Sanofi has announced that the UK's health technology assessor will conduct a new review of its Sarclisa (isatuximab) combo therapy for relapsed or refractory multiple myeloma. 13 November 2024
Pharmaceutical
The US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) today launched new advertisements urging Congress to make sure savings on medicines go to patients, not middlemen. 11 November 2024
Pharmaceutical
Danish patients are being offered fewer innovative treatments than Norwegians and Swedes, a new estimate from the Danish Medicines Council shows. 11 November 2024
Pharmaceutical
UK pharma major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2 polyneuropathy across England and Wales. 29 October 2024
Biotechnology
Last week Vertex Pharmaceuticals released positive Phase III results for its suzetrigine for moderate-to-severed pain. Belgium’s UCB revealed that Swiss pharma giant Roche was terminating its collaboration on the Alzheimer’s candidate bepranemab. The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) declined to recommend a second Alzheimer’s treatment, this time Eli Lilly’s Kisunla. Also of note, Lyell Immunopharma announced its planned acquisition of ImmPACT Bio and reprioritization of its own clinical pipeline. 27 October 2024
Pharmaceutical
The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines for breast cancer, providing a boost to Novartis' Kisqali (ribociclib). 24 October 2024
Biotechnology
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved US pharma major Eli Lilly’s (NYSE: LLY) Kisunla (donanemab) for people in Britain with mild cognitive impairment or those in the early stages of Alzheimer’s disease. 23 October 2024
Pharmaceutical
The US Department of Health and Human Services (HHS), through the Office of Assistant Secretary for Planning and Evaluation (ASPE), yesterday released new data showing that nearly 1.5 million people with Medicare Part D saved nearly $1 billion in out-of-pocket prescription drugs costs in the first half of 2024 because of the Biden-Harris Administration’s Inflation Reduction Act. 23 October 2024
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended elafibranor 80mg tablets for the treatment of PBC, the drug’s French developer Ipsen announced today. 22 October 2024
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) has released its final report assessing the effectiveness and pricing of key treatments for transthyretin amyloid cardiomyopathy (ATTR-CM). 22 October 2024
Pharmaceutical
Pharmaceutical Research and Manufacturers of America (PhRMA) says it has submitted comments to the Office of the United States Trade Representative (USTR) to inform the agency’s 2025 National Trade Estimate (NTE) Report on Foreign Trade Barriers. 21 October 2024
Pharmaceutical
“The new key figures from the NZa show that Dutch expenditure on expensive medicines remains stable,” says Mark Kramer, chairman of the Association of Innovative Medicines (VIG), adding: “That is good news from a social perspective.” 21 October 2024
Pharmaceutical
The Danish Medicines Council (Medicinrådet), responsible for evaluating and recommending new treatments for Denmark’s healthcare system, is facing a significant increase in processing times. 14 October 2024
Generics
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Biosimilars
South Korea’s Samsung Bioepis has released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States. 11 October 2024
Biotechnology
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Generics
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
Pharmaceutical
US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
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