Tuesday, August 20, 2024

EU Warns Of Anaphylaxis With MS Drug ‘Months Or Years' After Start Of Treatment

(8/19, Ian Schofield, Pink Sheet) ...Teva and EU medicines regulators have begun notifying health care professionals that cases of anaphylactic reactions to the multiple sclerosis drug, glatiramer acetate, have been reported in some patients immediately after administration but sometimes months or even years after they began their treatment. Some of the cases of anaphylaxis have been fatal, according to a Direct Healthcare Professional Communication drawn up by the European Medicines Agency in agreement with Teva and national regulators... Sub. Req'd

The Back-to-School Hunt for Adderall is On

(8/20, Tina Reed, Axios) ...While databases maintained by the FDA and the American Society of Health-System Pharmacists show a number of branded and generic ADHD drugs have come off shortage lists or soon will, supplies remain tight. Drugs like Adderall and other amphetamines like Vyvanse, as well as methylphenidate products like Concerta or Ritalin, are routinely missing from pharmacy shelves, said Adelaide Robb, the chief of psychiatry and behavioral sciences at Children's National Hospital. That's particularly the case for long-acting formulations that "last the whole school day," Robb told Axios. "Families are really struggling."... Full

Biogen Accused Of ‘Paying' PBMs To ‘Manipulate' US Generic Tecfidera Market

(8/20, Dean Rudge, Generics Bulletin) ...Spooked by the prospect of earlier-than-expected US generic competition to its powerhouse MS brand Tecfidera, Biogen entered into illicit agreements with PBMs to stifle generic competition while it "scrambled" to switch the market to its follow-on brand, a US class action lawsuit allege...According to the suit, PBM-affiliated specialty pharmacies enjoyed up to a 2000% markup on generic Tecfidera they had bought from manufacturers... Global Sub. Full

Biocon Expects US Adalimumab Market To Consolidate, Liraglutide Plans On Course

(8/19, Anju Ghangurde, Generics Bulletin) ...Biocon maintains it doesn't expect the US to remain an eight to 10 player market for adalimumab biosimilars for long and also outlines expectations for its GLP-1 portfolio, led by liraglutide, seen as a major growth driver in the coming years...A string of alliances with suppliers, including Teva Pharmaceutical Industries Ltd. and Alvotech 's private-label deal with Evernorth's Quallent Pharmaceuticals for a high-concentration interchangeable biosimilar to Humira, manufactured by Alvotech, and Boehringer Ingelheim's tie up with Quallent for an unbranded version of its own adalimumab biosimilar, have dotted the US landscape for the high-profile product... Global Sub. Full

Lundbeck Raises Financial Guidance Following Strong Growth

(8/20, The Pharma Letter) ...Denmark-based CNS specialist Lundbeck today reported financial results for the first six month of 2024, showing that total revenue rose 10% (+8% at constant exchange rates) to 10,741 million kroner ($1.58 billion), with all regions contributing to growth... Sub. Req'd

Granules India Receives US FDA Approval for Glycopyrrolate Oral Solution

(8/20, Pharmabiz.com) ...Granules India announced that the US Food and Drug Administration has approved its Abbreviated New Drug Application for glycopyrrolate oral solution 1mg/5mL filed by Granules Pharmaceuticals, Inc., a wholly owned foreign subsidiary of the company... Full

'We're Pretty Prolific': Lilly Catalyze360 Looks to Connect with Emerging Biotechs Across 'All Areas'

(8/19, Fraiser Kansteiner, Fierce Biotech) ...In recent years, Lilly has made major inroads—both internally and externally—into spaces like neurodegeneration, pain, diabetes, obesity and oncology. Beyond those fields, however, "I think all areas are on the table for us," according to Nisha Nanda, Ph.D., group vice president of business development for Catalyze360 at Lilly...Nanda emphasized the importance of "great science" and "excellent platforms" when it comes to Catalzye360's partnership focus. "We talk to companies all the time," she said. "We talk to venture capitalists all the time. We're open for business with anyone."... Full

Marksans Pharma Gets EIR from USFDA for Goa Facility

(8/20, Business Standard) ...Marksans Pharma has announced that it has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration, concluding the inspection as closed. The inspection has been classified as voluntary action indicated (VAI) and has been closed accordingly, the firm added... Full

Pfizer Brings Indian Generics Maker to Court Over Xeljanz Patent

(8/19, Nicole DeFeudis, Endpoints News) ...Xeljanz XR is an extended-release version of Pfizer's blockbuster JAK inhibitor for inflammatory conditions such as rheumatoid arthritis and ulcerative colitis. According to the FDA's Orange Book, it's covered by four key patents, three of which expire in 2034. Pfizer is suing Ajanta Pharma for alleged infringement of the fourth patent, dubbed RE41,783, which expires in December 2025... Full

Novel Targeted Therapies Show Superiority in Relapsed/Refractory CLL

(8/19, AJMC) ...Novel therapies demonstrated superior efficacy compared with immunotherapy and chemoimmunotherapy in patients with chronic lymphocytic leukemia (CLL) , according to a first-of-its-kind meta-analysis published in Therapeutic Advances in Medical Oncology... Full

Biosimilars, Originators Discontinued at Similar Rates for Inefficacy, Adverse Events

(8/20, Justin Cooper, Healio) ...Subcutaneous TNF inhibitors and their biosimilars are discontinued due to inefficacy and adverse events at similar rates in patients with rheumatic diseases, according to data from Spain published in The Journal of Rheumatology...However, the analysis found no statistically significant differences between the risks for discontinuation due to inefficacy or adverse events with originators vs. biosimilars... Full

A New Treatment for Severe Allergic Reactions — Without the Needle

(8/19, Teddy Rosenbluth, The New York Times) ...Dr. Michael Blaiss, an allergist at the Medical College of Georgia, was often surprised by how hesitant his patients were to use their auto-injectors, syringe-like devices like the EpiPen that deliver a drug needed to head off potentially fatal allergic reactions...A new device recently approved by the Food and Drug Administration may help quell some of the anxiety. The device, Neffy, administers epinephrine, the drug in the EpiPen, through a nasal spray rather than a needle. "We have needed this for so long," Dr. Blaiss said. "I truly believe it will save lives."... Sub. Req'd

Were Industry Watchers Too Optimistic After IRA's Price Cut Reveal? Analysts Weigh In

(8/19, Fraiser Kansteiner, Fierce Pharma) ...While analysts at Leerink Partners originally stated in a client note last week that price cuts were "not as bad as anticipated earlier this year," the team has since reversed its originally positive opinion, specifically regarding implications for oncology drugs. The team re-assessed its appraisal after reviewing an August report in the Journal of Managed Care & Specialty Pharmacy (JMCP) that estimated the 2021 net prices for the first 10 drugs included in Medicare negotiations... Full

Half of IRA Negotiation Savings to Come from Three Drugs, Brookings Finds

(8/19, Zachary Brennan, Endpoints News) ...For the first 10 drug prices negotiated under the Inflation Reduction Act, about one-half of the estimated $6 billion in Medicare savings is the result of negotiations for just three of those drugs, according to a new report from the Brookings Institution, a Washington, DC-based think tank... Full

Impact of Federal Negotiation of Prescription Drug Prices

(8/19, Anna Anderson-Cook and Richard G. Frank, Brookings) ...In this paper we provide an estimate of the savings realized through the negotiation process. The Centers for Medicare and Medicaid Services has reported that the reduction in spending associated with the new negotiated prices amounts to $6 billion evaluated at 2023 volumes of prescriptions. Our analysis examines the differences in the prices that were realized through negotiation by Part D plans and those obtained through the IRA's negotiation program for the 10 drugs selected for those negotiations... Full

The First-Ever Government Negotiation Process For Drugs Has Finished, But The Politics Are Ongoing

(8/19, Larry Levitt, Health Affairs) ...Here we focus on the political implications of the Drug Price Negotiation Program, what role it might play in upcoming elections, and what the outcome of the election might mean for the fate of drug price negotiations in the future... Full

Harris Plan to Cap Prescription Drug Costs is Likely to Increase Premiums

(8/20, Gabrielle M. Etzel, Washington Examiner) ...Vice President Kamala Harris's campaign plan to cap the costs of prescription drugs has some healthcare analysts warning that it would cause an increase in health insurance premiums, with the only debate being how much...One provision of the Inflation Reduction Act caps spending on insulin to $35 per month cap for Medicare beneficiaries. Harris is now calling for that cap to be imposed on all healthcare plans. Biden has alluded to the proposition of expanding the insulin price cap for several weeks and announced it publicly as a goal of his last few months in office... Full

Price Controls On Medicines for Obesity Will Not Make Them Easier to Get

(8/19, Kirsten Axelsen, RealClearHealth) ...Obesity medicines are the latest target of bad drug price policy ideas that distract from addressing the larger public health issues like prevention and insurance coverage. Federal intervention into obesity drug prices wouldn't solve the problem of lack of access to treatment. While not perfect, the competitive system in the U.S. has resulted in transformational science and affordable access to medicine in insurance plans. The policy effort should address the gaps in affordability and expand diagnosis and treatment... Full

Democratic Platform Favors Slate of Smaller Goals Over a Health Overhaul

(8/19, Rachel Cohrs Zhang, STAT Plus) ...The Democrats' platform, released Monday, is six times the length of Republicans' brief 16-page policy plan. The most impactful proposals require cooperation from Congress, which may not be decided in Democrats' favor, even if they are able to maintain the White House...This cycle, Democrats are focused on trying to fulfill their prior plans instead of pitching a major overhaul of the health care system... Sub. Req'd

Three Ways Drug Pricing Should Work in a Functioning Market, But Isn't

(8/19, Sandra Clarke, MedCity News) ...California led the nation by passing the first drug pricing transparency law in the country. Now more than half the states have similar laws. California can lead the way again by forcing transparency into PBM practices that drive up costs. At the same time, the state should begin building the infrastructure to independently establish the value of high-priced drugs. It could then create a maximum payment limit for these drugs—as many states are doing. These simple steps would go a long way to restoring balance in the broken drug pricing market... Full

Stakeholders Disagree Over How to Reform FDA's Advisory Committee System

(8/19, Ferdous Al-Faruque, Regulatory Focus) ...Some commenters argued that the agency should increase requirements for participating on the panels and ensure panelists continue voting on key issues such as the safety and efficacy of the products. However, others said the panels are too restrictive – preventing certain experts from participating – and argued for doing away with voting recommendations... Full

FDA Finalizes Guidance On PSG Meetings

(8/19, Joanne S. Eglovitch, Regulatory Focus) ...FDA received comments from industry on the draft version that expressed a need for better alignment with its GDUFA commitments. The final version accommodates a request by the Association for Accessible Medicines (AAM) and Teva to eliminate giving sponsors 60 days from the publication of a PSG to request a PSG teleconference...However, FDA rejected AAM and Teva's suggestion that it eliminate the distinction in the guidance between pre- and post-submission teleconferences. AAM said this delineation was not included in the commitment letter and was "inappropriate."... Full

Pre- and Post-PSG Telecons, Meetings, Etc. Outlined in New Final FDA Generic Guidance

(8/19, Bob Pollock, Lachman Consultants) ...Today, the FDA released a final guidance titled Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA...Here are a few specific examples of situations in which the Agency provides its advice regarding various meeting types and issues... Full

German Pharmaceutical Industry Warns of Possible Drug Shortages from China

(8/19, Tamsin Paternoster, Euronews) ...The German pharmaceutical industry has warning of possible drug shortages after China tightened its espionage laws. Four out of Germany's 16 states have now cancelled routine quality control trips to China by their inspectors as they're concerned they could fall foul of the law. The states say they can no longer guarantee the safety of their inspectors on visits to Chinese pharmaceutical factories... Full

Brexit & Covid Impact On UK Cancer Trials ‘Dissipating'

(8/19, Eliza Slawther, Pink Sheet) ...Brexit has been cited as a cause of the UK's 2020 decline in clinical trials, but research suggests that other global trends including the pandemic also had a large impact. Meanwhile, the MHRA's efforts to incentivize sponsors could boost trial figures "substantially," an expert says... Sub. Req'd

Union Minister JP Nadda Inaugurates 'First Policy Makers' Forum' in New Delhi

(8/20, ANI) ...To elevate India's position in the global pharmaceutical sector, the Indian Pharmacopoeia Commission, in collaboration with the Ministry of Health & Family Welfare and the Ministry of External Affairs, hosted an international delegation of policymakers and drug regulators from 15 countries. The forum featured the launch of innovative digital platforms for pharmacopoeia and drug safety monitoring... Full

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