Friday, April 12, 2024

Teva's Ajovy Hits Endpoint in Chinese Phase III Trial for Migraine Prevention

(4/11, Robert Barrie, Clinical Trails Arena) ...Teva Pharmaceuticals has unveiled positive data from a Phase III study evaluating Ajovy (fremanezumab) for the prevention of migraines in Chinese adult patients...Teva's chief medical officer Eric Hughes said: "China has the largest migraine population worldwide, and Teva is committed to research on a global scale that helps address an unmet need where it exists and ensure that the role of treatment innovations like Ajovy are better understood."... Full

Teva Confirms Efficacy in Late-Stage Trial of its Migraine Treatment for Adult Chinese Patients

(4/11, Nilanjana Basu, Seeking Alpha) ...Teva Pharmaceutical announced that late-stage study of AJOVY for the prevention of migraine in adult Chinese patients met primary and secondary goal. In the study, AJOVY achieved primary endpoint and all secondary endpoints, significantly reducing the number of migraine days experienced per month, demonstrating superior efficacy over placebo... Full

Pfizer Settles 12-Year-Old Lawsuit in Alleged Pay-For-Delay Scheme for $39M

(4/11, Kevin Dunleavy, Fierce Pharma) ..."Pfizer firmly believes that all claims that have been or are asserted against Pfizer's subsidiary Wyeth in this case are factually and legally without merit," Pfizer added. "As this case has already gone on for over twelve years, considerations led the company to determine that the proposed class settlement in this case is fair, reasonable and the best way to resolve this litigation." Teva does not factor in the settlement. Claims against the company remain active... Full

Hundreds of Drugs Are in Short Supply Around the U.S., Pharmacists Warn

(4/11, Kate Gibson, CBS News) ...In the first three months of the year, there were 323 active medication shortages, surpassing the previous high of 320 shortages in 2014, according to a survey by the American Society of Health-System Pharmacists and Utah Drug Information Service. It also amounts to the most shortages since the trade group started keeping track in 2001..."Ongoing national shortages of therapies for Attention-Deficit/Hyperactivity Disorder also remains an issue for clinicians and patients," they said... Full

Number of Ongoing US Drug Shortages Reaches New High, Pharmacist Group Says

(4/11, Fraiser Kansteiner, Fierce Pharma) ...In particular, doctors, pharmacists and patients have had to contend with inadequate stocks of chemotherapies, attention-deficit hyperactivity disorder meds, antibiotics like amoxicillin and other in-demand medicines...The group blamed certain supply shortages, in part, on quota changes at the Drug Enforcement Administration, alongside allocation practices set up in the wake of opioid legal settlements, which have exacerbated supply constraints on the controlled substances that currently comprise 12% of all active shortages... Full

Emboldened In Court, Lupin Launches First US Oracea Generic At Risk

(4/11, Dean Rudge, Generics Bulletin) ...Lupin has pressed ahead with launching the first generic version of Galderma's Oracea (doxycycline) modified-release capsule treatment for rosacea in the US, weeks after a US district court markedly found in the Indian's firm favor in patent-infringement litigation...In a short release, Lupin observed that doxycycline capsules had estimated annual sales of $128m in the US, citing IQVIA data... Global Sub. Full

Bausch Wins US Appeal to Block Alvogen Generic of Diarrhea Drug

(4/11, Blake Brittain, Reuters) ...A U.S. appeals court on Thursday affirmed a decision for Bausch Health that barred rival drugmaker Alvogen from marketing a proposed generic version of Bausch's diarrhea treatment Xifaxan until 2029...Bausch has said the litigation could affect its plans to spin off its eye-care business Bausch + Lomb. Analysts at Jefferies said on Thursday that the decision removes a "key barrier" for the spinoff. Bausch has separately agreed to allow Xifaxan generics from Teva Pharmaceuticals, Sun Pharmaceuticals and Sandoz starting in 2028 after settling related patent disputes... Full

Sun Pharma Receives OAI Status from USFDA for Dadra Facility

(4/12, Ruchika Sharma and Dr. Kamal Kant Kohli, Medical Dialogues) ...Sun Pharma has informed in a BSE filing that the US Food and Drug Administration has determined the inspection classification status of the Company's Dadra facility as Official Action Indicated..."We will work with the regulator to achieve fully compliant status," the Company added... Full

Celltrion Completes US Patent Registration for Zymfentra

(4/12, Jasmine Choi , Business Korea) ...Celltrion announced on April 11 that "Zymfentra" (the U.S. brand name for Remsima), the world's first subcutaneous formulation of infliximab for the treatment of autoimmune diseases developed in-house, has completed its formulation patent registration with the United States Patent and Trademark Office on April 9, local time... Full

Samsung Bioepis Secures 1st Approval in Korea for Stelara Biosimilar

(4/12, Lee Han-soo, Korea Biomedical Review) ...Samsung Bioepis has achieved a significant milestone by obtaining the first domestic approval for a biosimilar referencing Janssen's Stelara, Epyztek (ingredient: ustekinumab), on Thursday...Epyztek represents the fourth autoimmune treatment developed by Samsung Bioepis, following successful launches of biosimilars such as Etoloce (Enbrel biosimilar), Remaloce (Remicade biosimilar), and Adalloce (Humira biosimilar). The approval of Epyztek allows Samsung Bioepis to expand its portfolio to include an interleukin inhibitor, further enhancing its offerings for autoimmune disease treatments... Full

AstraZeneca's Fasenra Expands Approval in Children With Severe Asthma

(4/11, Nicole DeFeudis, Endpoints News) ...AstraZeneca's asthma treatment Fasenra will now be available to younger patients, heightening the competition in a crowded field of respiratory rivals. The FDA has expanded Fasenra's label to include the add-on maintenance treatment of children 6 to 11 years old with severe eosinophilic asthma. The drug was first approved in the 12-years-and-older setting in 2017... Full

Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032

(4/11, Skylar Jeremias, The Center For Biosimilars) ...The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare...The report specified that the rising prevalence of cancer and cost-effectiveness of biosimilars will be the main reasons behind the growth... Full

ICER Publishes Annual Unsupported Price Increase Report

(4/11, Thomas Sullivan, Policy & Medicine) ...Recently, the Institute for Clinical and Economic Review (ICER) published its annual Unsupported Price Increase Report, highlighting some of the unsupported price increases that took place in 2022. ICER has published these reports since 2019, with the aim of "assessing whether new clinical evidence or other information has appeared that could support the price increases of drugs whose recent, substantial price increases have had the largest impact on national drug spending."... Full

FDA Commissioner Calls On House Committee to Help Combat Drug Shortages

(4/11, Lia DeGroot, Endpoints News) ...FDA Commissioner Robert Califf appeared before the House Oversight Committee on Thursday to plead his case again for more authority to monitor the supply chain to prevent drug shortages...Califf emphasized that there are different driving forces of drug shortages, with shortages of less expensive generic drugs being reflective of supply chain issues. "The biggest shortages are occurring in inexpensive generic drugs where the less expensive the drug, the more likelihood of shortage because of the way the market is not succeeding in rewarding high-quality manufacturing. And that's the point I think we really need to address over the next few years," he said... Full

Murphy Advances Measure to Address Availability During Medication Shortages

(4/11, Senator Laura Murphy) ...State Senator Laura Murphy has advanced a measure that would make medications easier to obtain during shortages...Murphy's measure would require health insurance and managed care plans to cover brand-name prescription drugs if the generic drug is unavailable during a nationwide shortage... Full

Cuban Ready To Distribute Generic Drugs If CMS Agrees To March-In Alternative

(4/11, Maaisha Osman, InsideHealthPolicy) ...Mark Cuban, founder of the Mark Cuban Cost Plus Drug Company, tells Inside Health Policy he could take on the role of distributing the drugs should CMS back drug-pricing advocates' proposed march-in alternative to license entities to make generic versions of expensive drugs like Xtandi. The advocates tell IHP the proposal they shared with CMS this week could be used beyond Xtandi for other expensive drugs developed in part with taxpayers' funding... Sub. Req'd

Sandoz Shields Generic Drugs in Medicaid Rebate Program Suit

(4/11, Nyah Phengsitthy, Bloomberg Law) ...Sandoz Inc. is challenging the Centers for Medicare & Medicaid Services over any agency actions that would classify two of its products as innovator drugs under a government rebate program...The CMS stated in two letters to Sandoz that the agency's classification conclusions would become final in 30 days unless Sandoz objected. Sandoz objected because the two drugs are "quintessential generic drugs that should not be classified as innovator drugs under the MDRP statute," but rather, be identified as non-innovative drugs... Sub. Req'd

New Analysis: Flawed Assessments of a Medicine's Value Jeopardize Patient Access

(4/11, Nicole Longo, PhRMA) ...A recent analysis by Cencora (formerly Xcenda) looked at treatment options for five serious, complex medical conditions that are covered by Medicare Part B and have been evaluated by ICER. Cencora considered what would happen if the government adopted ICER's value assessments as the basis for its coverage decisions..."If the government used ICER-like assessments to set prices for medicines, many patients could lose access to the treatments that they and their physicians had previously determined were best for them based on individual needs and preferences, after careful consideration of the nuances of a patient's condition," explained Cencora... Full

Califf Suggests Congress ‘Tighten Up Laws' To Address Orange Book Abuses

(4/11, Sarah Karlin-Smith, Pink Sheet) ...To take more aggressive action against patent tactics used to thwart generic competition, Congress should work with the US Food and Drug Administration and Patent and Trademark Office to craft legislation, FDA Commissioner Robert Califf said...The patent listings in the Orange Book are used to determine when generics can enter the market. Califf repeated a long-standing FDA refrain that its role with the Orange Book "is ministerial," saying the agency has "not much discretion" in adding the patents and would get sued if it declined to list them... Sub. Req'd

FDA Officials Offer Advice for Successful Suitability Petitions

(4/11, Joanne S. Eglovitch, Regulatory Focus) ...US Food and Drug Administration officials discussed how the generic drug industry can improve the quality of their suitability petitions and avoid rejections as part of the agency's commitment to conduct more timely reviews of these petitions at the Generic Drug Forum sponsored by FDA's Small Business and Industry Assistance Program on April 10. The meeting was held virtually and on-site in Bethesda, MD... Full

Industry Calls On G20 To Boost Regulatory Harmonization & Tackle AMR

(4/11, Ian Schofield, Pink Sheet) ...The international pharmaceutical industry has urged the governments of the G20 countries to take action to promote convergence and harmonization of regulatory requirements and to preserve intellectual property system protections in their national policies. It also wants the G20 governments to take steps to foster a "viable antibiotic R&D ecosystem" to help tackle antimicrobial resistance, and to look at ways of addressing funding gaps in the treatment of neglected tropical diseases... Sub. Req'd

European Parliament Votes in Favor of Updated Pharma Legislation, Prompting Mixed Reactions

(4/11, Ed Silverman, STAT Plus) ...The European Parliament has voted overwhelmingly to adopt legislation that is supposed to transform the way medicines are brought to market and accessed across much of Europe. But the effort - which must still be approved by the European Council - drew mixed reactions from the pharmaceutical industry and consumer groups...This is "a step towards delivering the tools to tackle present and future healthcare challenges, particularly for our market attractiveness and medicine access across EU countries," said Pernille Weiss, a member of parliament and rapporteur for the directive, in a statement... Sub. Req'd

European Parliament Adopts Pharmaceutical Reform Package

(4/11, Ferdous Al-Faruque, Regulatory Focus) ...If the legislation and regulations are adopted as is, drugmakers will have at least seven and a half years of regulatory data protection after receiving marketing authorization, down from eight years under the current legislation, in addition to two years of marketing protections for their drugs against rival companies that may want to manufacture generics, hybrids, or biosimilars... Full

Sweden Aims to Keep Current Data Protection Period in EU Pharma Package

(4/11, Monica Kleja, Euractiv) ...The Swedish government is opposed to shortening the regulatory data protection period for new medicines, as currently proposed by the EU Commission in its pharma legislative overhaul. Swedish key stakeholders are demanding a stronger focus on patients and healthcare... Full

Access to New Medicines in Canada, Europe, and the United States: Study Finds Less Availability and Longer Waits for Canadian Patients

(4/11, The Canadian Health Policy Institute) ...Data showed that Canada was a low priority market for new drug launches. The number of new drug applications submitted in Canada was only 54% of the number launched in the United States, and 62% of those launched in the European Union. Health Canada subsequently approved fewer new drugs compared to the European Medicines Agency and the US Food and Drug Administration. Only 69% of the new drugs authorized for marketing in the United States were also approved in Canada. Of the drugs authorized for marketing in the EU, 78% were also approved in Canada... Full

Stronger Focus On Generic Medicines Could Save HSE Cash, Says Industry Report

(4/11, Dominic Coyle, The Irish Times) ...Ireland's health system is wasting money on medicines by hindering access to generic drugs, according to an industry group. Medicines for Ireland says health policy decision-makers need to recognise how "increased penetration of generic, biosimilar, and value-added medicines offers significant savings to the State" as well as a chance to treat more patients earlier when they are ill... Full

Indian Pharmaceutical Company Sets Up Shop in Jamaica

(4/11, Loop News) ...Minister of Industry, Investment and Commerce, Senator Aubyn Hill, has welcomed the Indian multinational company, Dr. Reddy's Laboratories, to Jamaica. Speaking at the launch on Wednesday at its location in the Insurance Company of the West Indies corporate offices in New Kingston, the minister noted that the presence of the pharmaceutical giant in Jamaica is another dimension of cooperation between both countries... Full

NPPA Releases Draft Ceiling Price Calculation Sheets of Seven Scheduled Formulations

(4/12, Pharmabiz.com) ...The National Pharmaceutical Pricing Authority has announced the draft version of calculation of ceiling price for seven formulations including pneumococcal vaccine 0.5ml, oral rehydration salts, and cloxacillin 250 mg and 500 mg capsules, for the response from the stakeholders... Full

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