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.
Chugai Pharmaceutical has announced its final victory in a lawsuit in which it sought injunction against generic drug manufacturers based on infringement of the process patent (Patent No 3310301 on Oxarol. 27 March 2017
The US Food and Drug Administration under the US President's Emergency Plan for AIDS Relief (PEPFAR) has approved the New Drug Application for efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, 400mg/300mg/300mg ("TLE400"). 21 March 2017
Stada Arzneimittel yesterday confirmed current media reports that the expert sessions which were planned as part of the structured bidding process have been postponed based on the decision of the supervisory board. 17 March 2017
When one of the year’s major events in Japanese pharma returns next month, the issues of an aging population, growing healthcare costs and the government’s attempts to address them are certain to crop up. 16 March 2017
Shares in Hikma Pharmaceuticals are up over 7% today on the news that the Jordanian drugmaker beat expectations in its 2016 financial results statement. 15 March 2017
Indian drug major Sun Pharmaceutical Industries said yesterday that the US Food and Drug Administration will lift the Import Alert imposed on the Mohali (Punjab) manufacturing facility and remove the facility from the Official Action Initiated (OAI) status. 15 March 2017
Hot on the heels of another generics giant, Netherlands-based Mylan has launched a generic version of Pristiq (desvenlafaxine) extended-release tablets in the USA. 10 March 2017
Indian drugmaker Zydus Cadila has announced that it has finalized an agreement with the USA’s Supernus Pharmaceuticals to settle all outstanding patent litigation related to Trokendi XR (topiramate) extended-release capsules. 7 March 2017
Created in the Medicare Modernization Act of 2003, and formally implemented in 2006, a US program aimed at providing affordable prescription drugs to seniors and people living with disabilities has had a dramatic impact, a study shows. 7 March 2017
The UK’s Competition and Markets Authority (CMA) today alleged that Concordia and Actavis UK signed illegal agreements which enabled high prices for a life-saving drug to be prolonged. 3 March 2017
Teva Pharmaceutical Industries and India’s Lupin both yesterday announced the launch of their copy versions of Pristiq (desvenlafaxine) extended-release tablets in the USA. 2 March 2017
The full-year and fourth quarter 2016 financial results statement from generics and specialty drugmaker Mylan seems to show the company has left its EpiPen troubles behind. 1 March 2017
Canada’s Valeant Pharmaceuticals International has released fourth-quarter and full-year 2016 results, showing that revenue fell 12.9% to $2.40 billion for the quarter, but exceeded the average expectation of $2.33 billion. 28 February 2017
The timing of the release of statistics showing that 2016 was a record year for the US Food and Drug Administration’s (FDA) generic drug program “couldn’t be better amid concerns about rising drug prices,” according to a senior figure at the agency. 28 February 2017
Pernix Therapeutics has received a favorable patent infringement ruling against Actavis Laboratories regarding a proposed generic version of opioid pain treatment Zohydro ER (hydrocodone bitartrate). 23 February 2017
Stada Arzneimittel says it has today received a legally binding offer from Advent International Corp regarding the acquisition of up to 100% of the German generic drugmaker. 23 February 2017
Swiss pharmaceutical firm Dipharma has announced that the European Medicines Agency has validated its Marketing Authorization application for Disanit. 23 February 2017
Momenta Pharmaceuticals announced that Sandoz’s contracted fill/finish manufacturing partner has received a US Food and Drug Administration warning letter. 20 February 2017
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.