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.
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
USA-based generics major Viatris and Kindeva Drug Delivery today announced the launch of Breyna (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, the first generic version of AstraZeneca's Symbicort with an Abbreviated New Drug Application (ANDA) approved by the US Food and Drug Administration (FDA). 1 August 2023
Building up on its sizeable global presence in the oncology space, Venus Remedies, an India-based provider of affordable cancer drugs worldwide, has extended its reach with marketing approvals for key cancer drugs from Philippines, Paraguay, Georgia and Moldova. 31 July 2023
Prices for imported active pharmaceutical ingredients (APIs) are rising again in Russia after the decline in 2022. This year the growth is equivalent to by 40%-100% year-on-year due to the devaluation of the rouble and the need to use intermediaries for these procurements, reports The Pharma Letter’s local correspondent. 20 July 2023
As the US market prepares to go through a major upcycle following a seven-year downcycle, with numerous key indicators aligning at the same time, Indian pharmaceutical companies are waiting in the wings, poised to leverage the significant opportunity in the small molecule patented drugs segment, reports The Pharma Letter’s India correspondent. 17 July 2023
Colombia, which is home to a $4.8 billion pharma market, will soon decide whether to authorize price-cutting generic competition with a critical patented AIDS drug, directly challenging pharmaceutical industry power under a new health ministry resolution in one of the hemisphere’s most influential states. 14 July 2023
Global drugmakers continue to defend the rights for their original drugs in Russia by participating in legal disputes with local generics’ producers, The Pharma Letter’s local correspondent reports. 12 July 2023
The High Court has issued a judgment on the judicial review brought by the British Generic Manufacturers Association (BGMA) dismissing the claim that the organization was improperly excluded from the ongoing negotiations between the government and industry to agree a new Voluntary Scheme for medicine pricing and access (VPAS). 10 July 2023
The Russian Ministry of Health has called on domestic drugmakers to accelerate efforts for the development and production of cheaper analogues of expensive drugs, particularly those that are used for the treatment of socially significant diseases, according to recent statements made by Sergey Glagolev, deputy head of the Ministry. 4 July 2023
Swiss generic drugmaker Dipharma today announced that its product Sapropterin Dipharma is now available in main European countries including in Switzerland. 3 July 2023
As part of an initiative to reduce global dependence on China for the supply of crucial pharmaceutical and active pharmaceutical ingredient (API) requirements, India and the USA have agreed to collaborate on the development of APIs and vaccine materials. 28 June 2023
AstraZeneca has called on the Russian Ministry of Health to change the conditions for registering prices for generics in Russia, as the current rules, according to the company, prevent original drugmakers from participating in public procurements, reports The Pharma Letter’s local correspondent. 27 June 2023
Japanese pharma major Shionogi has signed seven sublicence agreements with the Medicines Patent Pool (MPP), a United Nations-backed international public health organization, for generic version of Shionogi's ensitrelvir fumaric acid, a COVID antiviral, to be manufactured by generics companies. 26 June 2023
India has made it clear that it will not compromise on intellectual property, regulatory data protection, and patent extension as part of ongoing trade negotiations with the UK and the European Union. 22 June 2023
Four companies in the Asia Pacific region have taken out licenses with The Medicines Patent Pool (MPP) to manufacture generic versions of Tasigna (nilotinib). 22 June 2023
The US Federal Trade Commission has filed a friend-of-the-court (amicus) brief in the US Court of Appeals for the Second Circuit, clarifying the legal standards that apply in certain antitrust cases involving the pharmaceutical sector. 21 June 2023
The Delhi High Court has sought the Indian government's position regarding a petition that challenges the ban on fixed-dose combination (FDC) drugs, reports The Pharma letter’s local correspondent. 20 June 2023
The total contribution that the pharmaceutical industry has provided for the Bulgarian economy in 2021 is estimated at around 2.8 billion Bulgarian lev ($1.57 billion) or 2.2% of the country's gross domestic product (GDP), which is in line with the average level for Europe. 19 June 2023
The UK subsidiary of Hungarian drugmaker Gedeon Richter today announced that full marketing and distribution rights to an oral contraceptive range of branded generics, acquired from Ireland-headquartered Consilient Health, have been transferred to the company. 14 June 2023
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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.