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 if the Indian drug major has not had enough negative news from the US regulator, the US Food and Drug Administration yesterday notified Ranbaxy Laboratories that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. 24 January 2014
Generics drug major Actavis has confirmed that its Watson Laboratories unit has submitted an Abbreviated New Drug Application with the US Food and Drug Administration for approval to market a generic version of Allergan’s ophthalmic drug Restasis(cyclosporine ophthalmic emulsion) 0.05% product. 22 January 2014
US privately-held Par Pharmaceutical has entered into a definitive agreement to acquire JHP Group Holdings, the parent company of JHP Pharmaceuticals, a specialty pharmaceutical company that develops, manufactures and markets branded and generic sterile injectable products, headquartered in New Jersey. 21 January 2014
US generics major Actavis plans to enter into an agreement with India’s Aurobindo Pharma for the latter to acquire Actavis' generics commercial operations in seven markets in Western Europe. No financial terms of the proposed transaction were revealed. 18 January 2014
Privately-owned US generics firm Alvogen revealed that, last month, it agreed to become the majority shareholder in Taiwanese Lotus Pharmaceuticals through a private placement of newly issued shares, acquiring up to 151 million shares in the company. 17 January 2014
Following the Official Gazette market application filling for the drug atazanavir sulfate, an HIV protease inhibitor, on January 13, the Institute of Pharmaceutical Technology (Farmaguinhos/Fiocruz will be responsible for production of the drug. 15 January 2014
US generics and specialty drugmaker Actavis has announced an updated business structure for its US Specialty Brands business designed to maximize the company's newly-strengthened position in key therapeutic areas and position it for continued long-term growth. 14 January 2014
Somewhat sooner than expected, Isael’s Teva Pharmaceutical Industries, the world’s largest generics drugmaker, has confirmed recent reports, saying that Erez Vigodman has been appointed president and chief executive, effective February 11. 9 January 2014
The Canadian subsidiary of Ranbaxy Laboratories has received approval to manufacture and market RAN-Donepezil Hydrochloride 5mg and 10mg tablets, a generic version of Japanese drug major Eisai’s Aricept, from Health Canada. 8 January 2014
Overall national health expenditures in the USA grew at an annual rate of 3.7% in 2012, marking the fourth consecutive year of low growth, the Centers for Medicare & Medicaid Services (CMS) Office of the Actuary reported this week. 7 January 2014
Speculation is mounting that Israel’s Teva Pharmaceutical Industries is about to appoint a new chief executive, after ousting 18-month incumbent of the post, Jeremy Levin, last October. 7 January 2014
Privately-held US generics drugmaker Amneal Pharmaceuticals has announced the launch of generic esomeprazole strontium delayed-release capsules 49.3mg. 7 January 2014
Israel’s Teva Pharmaceutical Industries, the world’s largest generic drugmaker, says it has launched the authorized generic of Detrol LA (tolterodine tartrate extended-release capsules) 2mg and 4mg in the US market. 4 January 2014
US drugmaker Mylan says that Rakesh Bamzai has joined the company and has been appointed president, India commercial and emerging markets. 4 January 2014
With the commencement this year of manufacturing and selling generic copies of the hypercholesterolemia agent Livalo (pitavastatin) , manufactured and sold by privately-held Japanese drugmaker Kowa, the latter, along with Nissan Chemical intend to bring legal actions against the generic drug marketing authorization holders. 30 December 2013
The US Food and Drug Administration’s Center for Drug Evaluation and Research has approved plans to elevate the Office of Generic Drugs to an office that reports directly to the center director. This reorganization will strengthen OGD’s operations and enable the office to meet the evolving needs of generic drug review. 29 December 2013
China’s Shenzhen Hepalink Pharmaceutical has entered into a stock purchase agreement to acquire USA-based Scientific Protein Laboratories, a leading global, independent manufacturer and supplier of active pharmaceutical ingredients (APIs). 27 December 2013
Emerging US generic drugmaker ANI Pharmaceuticals says that it has acquired 31 previously marketed generic drug products from Israeli generics giant Teva Pharmaceutical Industries. 27 December 2013
Taipei-based biopharmaceutical company Taiwan Liposome Company has entered into a collaboration agreement with Sandoz, the generics division of Swiss drug major Novartis. 19 December 2013
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
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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.