3 October 2024 F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic.
As part of its efforts to bring more drug competition to the market and address the high cost of medicines, the US Food and Drug Administration has published an update to the List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (OPOE list). 23 June 2021
Prices for imported pharmaceutical substances are steadily increasing in Russia, which creates serious problems for domestic drugmakers, whose costs have also grown significantly in recent months, according to a recent study, conducted by a local analytics company RNC Pharma, reports The Pharma Letter’s local correspondent. 22 June 2021
The European Commission has approved, under the EU Merger Regulation, the acquisition of joint control of Lonza Specialty Ingredients of Switzerland by USA-based Bain Capital Investors and Cinven Capital Management of the UK. 21 June 2021
In a move that will help ensure sub-standard or counterfeit drugs do not reach customers, India's Health Ministry is looking to make it mandatory for companies to include codes to track-and-trace key ingredients used to make medicines in India. 17 June 2021
The UK subsidiary of Indian drugmaker Lupin Limited today announced it has received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to market Luforbec (beclomethasone/formoterol) 100/6 dose pressurized metered dose inhaler (pMDI), the first branded generic of Fostair. 14 June 2021
The Indian government has offered 55 drugmakers $2.06 billion in production-linked incentives (PLI) for six years through fiscal year 2029 to boost manufacturing of medicines, in-vitro diagnostics and their raw materials. 8 June 2021
Specialty pharma company TLC and India-based Strides Pharma Science have teamed up to help alleviate the recent surge in COVID‐19 associated mucormycosis cases in the Asian country. 2 June 2021
A sharp rise in the price of raw material of key drugs used in the treatment of COVID-19, as well as other active pharmaceutical ingredients (API) over the last few weeks, has unnerved Indian drug manufacturers. 1 June 2021
The UK’s Competition Appeal Tribunal (CAT) has upheld the CMA decision that pharma major GlaxoSmithKline (LSE: GSK) and some generic suppliers of the anti-depressant paroxetine broke competition law. 12 May 2021
Swiss contract development and manufacturing organization (CDMO) Lonza today announced it will invest around 850 million Swiss francs ($934 million) to expand its mammalian drug substance manufacturing facilities in Visp, Switzerland, and Portsmouth, USA. 6 May 2021
Indian drugmaker Glenmark Pharmaceuticals has announced the launch of Ryaltris-AZ Nasal Spray for the treatment of moderate to severe allergic rhinitis, in India. 4 May 2021
London-listed Hikma Pharmaceuticals saw its share gain more than 2% to 2,415 pence by late morning, as the company, announces the approval of Kloxxado (naloxone hydrochloride) nasal spray 8mg, by the US Food and Drug Administration for the emergency treatment of known or suspected opioid overdose. 30 April 2021
Teva Pharmaceutical Industries yesterday reported results for the first quarter of 2021 that met earnings expectations but not sales, leading the Israeli generics giant’s shares nearly 2% lower at 3,271 shekels by close of trading on Wednesday. 29 April 2021
The Russian government plans to stimulate the production of active pharmaceutical ingredients (APIs) for the domestic sector, as part of a recent order by the country’s President, Vladimir Putin. 27 April 2021
Swiss contract development and manufacturing organization (CDMO) Lonza today announced the construction of a new small molecule manufacturing complex at its Visp (CH) site. 23 April 2021
Ahead of CPhI Discover (May 17-28, 2021) – global pharma’s largest virtual gathering – the CPhI executive post-pandemic pharma survey predicts that pandemic supply chain issues have further cemented a push for repatriated manufacturing globally. 22 April 2021
London-listed Hikma Pharmaceuticals says it has resumed the launch of its generic version of GlaxoSmithKline’s Advair Diskus in the USA, following US Food and Drug Administration approval of an amendment Hikma submitted to its Abbreviated New Drug Application in January 2021. 21 April 2021
Russian pharmaceutical production is booming, according to latest statistics provided by some leading analyst agencies in the field of pharmaceutics and local media reports. 20 April 2021
Serum Institute of India (SII) chief executive Adar Poonawalla has appealed to US President Joe Biden to lift the US embargo on exporting raw materials to help ramp up COVID-19 vaccine production. As the world grapples with vaccines short supply, Mr Poonawalla has flagged the US embargo on raw material exports. 19 April 2021
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 4 October 2024
US antivirals giant Gilead Sciences today announced that it has signed non-exclusive, royalty-free voluntary licensing agreements with six generic drugmakers to make and sell generic lenacapavir 2 October 2024
The US Food and Drug Administration (FDA) yesterday released its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report. 2 October 2024
The number of clinical trials of new drugs in Russia is steadily declining, which could be mainly related with the overall reduction of investment activities in the local pharmaceutical market, reports The Pharma Letter’s local correspondent. 30 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
The protection of intellectual property (IP) rights of foreign pharmaceutical companies in Russia remains complex situation, according to recent statements by Konstantin Panurovsky, legal director of AstraZeneca’s Russian subsidiary, reports The Pharma Letter’s local correspondent. 13 September 2024
The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” 12 September 2024
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
A significant drop has been noticed in the prices of active pharmaceutical ingredients (APIs), bringing much-needed relief to the pharmaceutical industry and potentially translating to lower drug costs for consumers. 9 September 2024
Glenmark Pharmaceuticals has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug, the US Department of Justice announced. 5 September 2024
German pharma major Bayer has filed a lawsuit against the Russian drugmaker Promomed to protect the patent rights for Xarelto (rivaroxaban), its treatment for stroke prevention which is the best-selling drug in the Russian market at present, The Pharma Letter’s local correspondent reports. 2 September 2024
German generics major STADA Arzneimittel today announced that it achieved sales of more than 2 billion euros ($2.23 billion) in the first half of 2024. 28 August 2024
In a major crackdown, the Indian government has imposed an immediate ban on 156 fixed-dose combination (FDC) drugs, including commonly used antibiotics, pain relievers,and multivitamins. 27 August 2024
Swipha, a leading Nigerian pharmaceutical manufacturer, has received prequalification from the World Health Organization (WHO) for its sulfadoxine-pyrimethamine (SP) drug. 21 August 2024
One of the largest pharmaceutical production facilities in the Russian North-West region will soon be built in the city of Pushkino by the local drugmaker Active Component enterprise, The Pharma Letter’s local correspondent reports. 14 August 2024
Even as Novartis (NOVN: VX) is locked in a high-stakes battle with the US Food and Drug Administration (FDA) to protect its blockbuster heart failure drug Entresto (sacubitril and valsartan) from generic competition, generic versions of valsartan are making hay in India 8 August 2024
The Russian Ministry of Health has registered the third Russian generic of the original drug Ozempic (semaglutide) from Danish drugmaker Novo Nordisk. 8 August 2024
US biotech major Biogen is disputing the launch of a Russian generic of Spinraza (nusinersen), a drug, which is used to treat spinal muscular atrophy (SMA), reports The Pharma Letter’s local correspondent. 7 August 2024
Imports of bulk drugs from China have jumped, potentially undermining India's efforts to boost domestic pharmaceutical manufacturing through its Production Linked Incentive (PLI) scheme. 5 August 2024
Sign up to receive email updates Join industry leaders for a daily roundup of biotech & pharma news
Company Spotlight
A pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases.