Monday, June 24, 2024

‘A True Seat At The Table' – Irish Industry Leader Sets Out Aspirations For New Pricing Deal

(6/21, David Wallace, Generics Bulletin) ..."The off patent industry needs, and in fact must have, a true seat at the table." That is how Paul Neill – country manager at Teva Ireland, and chair of industry association Medicines for Ireland – summarizes the importance of greater off-patent industry involvement in policymaking, including most notably a new pricing agreement with the country's government that is expected at the end of 2025... Global Sub. Full

‘In It For The Long Haul‘ – Celltrion Remains Committed To US Biosimilars

(6/24, David Wallace, Generics Bulletin) ...Almost a year after launching Celltrion's Yuflyma rival to Humira in the US, Tom Nusbickel, chief commercial officer of Celltrion USA, reflects on experiences in the market so far and key launches on the horizon, in an exclusive interview with Generics Bulletin..."From Celltrion's perspective, we've always been in it for the long haul," Nusbickel tells Generics Bulletin in an exclusive interview. "We've invested in building this commercialization unit in the US (see sidebar). We have a broad pipeline, multiple biosimilars."... Global Sub. Full

US FDA Approves Roche's Drug for a Chronic Blood Disorder

(6/24, Puyaan Singh, Reuters) ...The U.S. Food and Drug Administration on Thursday approved Roche's drug for a chronic blood disorder, the Swiss drugmaker said. The drug crovalimab, branded as PiaSky, is a monthly under-the-skin or intravenous treatment for paroxysmal nocturnal hemoglobinuria... Full

Biocon Biologics Gets EMA Nod to Manufacture Biosimilar Bevacizumab Used in Cancer Treatment

(6/24, CNBC TV 18) ...Biocon on Monday, June 24, said its subsidiary, Biocon Biologics, has secured approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab, used in cancer treatment, at its new facility in Bengaluru, Karnataka. This approval will significantly enhance the capacity to meet patients' needs across European markets, the biotechnology firm said in a stock exchange filing... Full

FDA Ships Two Form 483s to Dr. Reddy's for Two Separate Sites in India

(6/21, Anna Brown, Endpoints News) ...The two open Form 483s relate to two Dr. Reddy's sites in the southeast Indian state of Andhra Pradesh, after inspections made in May and June. "None of our plants are under Official Action Indicated (OAI), Warning Letter (WL) or any sort of escalation. All of them maintain a state of compliance," a spokesperson for Dr. Reddy's told Endpoints News in an email... Full

Lupin, Eugia Recall Products from US Over Manufacturing Issues: USFDA

(6/23, Press Trust Of India) ...Baltimore-based Lupin Pharmaceuticals Inc is recalling 3,552 bottles of Cefixime for Oral Suspension (USP 200 mg/5 mL) due to "failed content uniformity specifications"...The US health regulator stated that New Jersey-based Eugia US LLC, a subsidiary of Aurobindo Pharma, is recalling 70,125 vials of Dexamethasone Sodium Phosphate injection USP. The company is recalling the affected lot due to "failed impurities/degradation specifications", USFDA said... Full

Biosimilars Gain a Foothold in Challenging Market

(6/22, Karen Blum, Pharmacy Practice News) ...About 39 biosimilars have launched across several therapeutic areas, including oncology, supportive care, immunology, endocrinology and ophthalmology, but adoption has been uneven, speakers said during several sessions at Asembia's AXS24 Summit, in Las Vegas...These events could be a bellwether for how biosimilars are moving, said Cate Lockhart, PharmD, PhD, the executive director of the Biologics and Biosimilars Collective Intelligence Consortium... Full

Podcast: A Closer Look at 'Friend-Shoring' and the Drug Shortage Challenge

(6/21, Ayla Ellison, Zoey Becker, Fierce Pharma) ...In this week's episode of "The Top Line," Fierce Pharma's Zoey Becker sits down with Bobby Sheng, the CEO of Bora Pharmaceuticals...Sheng discusses the criteria for deeming a country "friendly" and explores whether this strategy could help address drug supply shortages... Full

‘A Critical Step.' California Offers Free Naxolone to Qualified Organizations. Here's How

(6/23, Ishani Desai, The Sacramento Bee) ...Qualifying organizations can now apply to receive free over-the-counter naxolone, an opioid reversal drug sold under the brand name Narcan, from the state...California contracted with Amneal Pharmaceuticals to buy the drug at a 40% reduction, according to an announcement of the purchase. "By making Naloxone widely available and affordable, we are empowering communities and saving lives," said California Health and Human Services Agency Secretary Dr. Mark Ghaly, who heads the department providing the drug. "This is a crucial step in our ongoing efforts to tackle the opioid crisis head-on."... Sub. Req'd

US Product Hopping Legislation Could Offer $3Bn In Savings

(6/24, Urte Fultinaviciute, Generics Bulletin) ...In the ongoing fight for fair market competition and improved medication access, the US Congressional Budget Office calculated $3bn in savings from a bill that would prevent originators from product hopping...The enactment of the bill would lower the average prices for prescription drugs and biologics, resulting in lower federal spending. Also, budgetary savings could stem from "lower spending on federal subsidies for health insurance programs that cover drugs and biological products."... Global Sub. Full

New CBO Scores May Boost Chances For Drug Patent Bills In Year-End Spending Package

(6/21, Gabrielle Wanneh, InsideHealthPolicy) ...A bill that aims to curb product hopping, patent thickets and other tactics brand drug makers use to delay generic and biosimilar market entry is now projected to save the government roughly $3 billion, nearly $2 billion more than what the Congressional Budget Office projected back in 2022. The jump in savings for this -- combined with two other drug competition and patent reform bills estimated to jointly save over $2 billion -- may significantly increase the likelihood of lawmakers including the bills as a pay-for in a year-end health care spending package... Sub. Req'd

IDP Analytics' Jeffrey Casberg Says IRA, PBM Legislation Reshape US Drug Costs

(6/23, Cameron Santoro, The Center For Biosimilars) ...In an interview with Jeffrey Casberg, RPh, MS, senior vice president of pharmacy at IDP Analytics, discussed policy changes and market forces that are impacting the cost of drugs. Casberg explained why he felt the Inflation Reduction Act and pharmacy benefit manager legislation are the most impactful... Full

NYT Article On PBMs Draws PCMA's Ire, Pharmacy Group's Praise

(6/21, Jessica Karins, InsideHealthPolicy) ...The PBM lobby, the Pharmaceutical Care Management Association (PCMA), responded to the article with ire Friday. CEO JC Scott said in a statement it was "designed from the beginning to fit predetermined conclusions about the PBM industry and advance an agenda that shares common cause with the pharmaceutical industry." "The article lacks data and instead relies on a handful of anecdotes to make broad assertions. It disregards the role of the rest of the prescription drug supply chain, including giving brand name drug companies a free pass despite their sole power to set prices on the products they market, the majority of which are unaffected by negotiations with PBMs because they face no competition in the marketplace," Scott wrote... Sub. Req'd

Overpaying for Medicine

(6/21, Rebecca Robbins and Reed Abelson, The New York Times) ...Until recently, regulators had generally given P.B.M.s. a pass. That's changing as high drug prices have prompted more scrutiny. The Federal Trade Commission, lawmakers and state attorneys general have suggested that the P.B.M.s. may be abusing their power. "They're seeking to extract from the system without creating any corresponding value for the system," said Dave Yost, the Republican attorney general in Ohio who has sued Express Scripts and Optum Rx over their business practices. "The patients are the ones that are suffering."... Sub. Req'd

Making Drugs Affordable. There is Disagreement About The Recipe | AHIP 2024

(6/21, Peter Wehrwein, Managed Healthcare Executive) ...The lively discussion among Merith Basey, M.Sc., Vin Gupta, M.D., M.St., M.P.A., and Adam Kautzner, Pharm.D., did feature some areas of overlap. There was, for example, some shared finger pointing at pharmaceutical companies for setting high list prices and a shared opinion about the importance of biosimilars to bringing down the price of biologics... Full

Biosimilars Council Applauds Updated FDA Guidance On Interchangeability

(6/21, Biosimilars Council) ..."Biosimilars – with and without an interchangeability designation – are safe and effective, and lower price options for patients," said Craig Burton, Executive Director, Biosimilars Council. "This FDA action is consistent with the Council's recommendations and will maintain the FDA's high standards of safety while speeding up patient access to essential medicines."... Full

The High-Shortage Generic Market

(6/22, Gina Shaw, Pharmacy Practice News) ...The Senate Committee on Finance released a bipartisan discussion draft about legislation to tackle drug shortages—in particular, the low-margin generic sterile injectables that are backbone products in hospitals and health systems... Full

To Reduce Drug Prices, Issue Fewer Weak Patents

(6/22, Avik Roy, Forbes) ...There are two unusual things about patent law that we don't talk about nearly enough. The first is that the patent system is subjective. Even the most sincere and dedicated patent examiners at the U.S. Patent and Trademark Office are capable of making misjudgments about whether or not a patent application should be approved...The second problem is that the patent system is one size fits all. Every issued patent, irrespective of its importance or innovativeness, gets the same 20-year monopoly rights from USPTO, and from other countries through trade agreements. It's the combination of these two problems that impairs the patent system... Full

AAM Knocked Back In Illinois Price-Gouging Lawsuit

(6/24, Dean Rudge, Generics Bulletin) ...The US Association for Accessible Medicines has seen dismissed by a US district court a lawsuit it filed in Illinois earlier this year seeking to block the enforcement of a state price-control bill. The AAM had termed it an "unconstitutional overreach" and warned that the bill would likely lead to fewer generic alternatives and less competition... Global Sub. Full

Availability of Treatment in Slovakia Within the Framework of European Legislation - Expert Forum Brings Solutions

(6/24, Medicines for Europe) ...The international conference Expert Forum, organized by the GENAS association, attracted key healthcare players to Bratislava on Monday, including representatives from the European Commission (DG SANTE), the Permanent Representation of the Slovak Republic to the EU, Medicines for Europe, Slovak and European experts and analysts. The participation of significant stakeholders underscores the importance of the topic of treatment availability and the need for discussion on current challenges and solutions, all in the context of the ongoing revision of EU pharmaceutical legislation... Full

Health Council to Grapple with Incentives in Pharma Package

(6/21, Catherine Feore, Euractiv) ...Striking a balance between incentivising innovation and improving access to medicines has been one of the central issues in the debate on the future pharma package with stakeholders having a significant divergence in views. Medicines for Europe, which represents the generic, biosimilar and value-added medicines industry, argues that ministers should "prioritise equitable access for all patients."... Full

UK Election Pledges: ‘Nimble' Regulation, an MRA With the EU, Faster Access & More Efficient Trials

(6/21, Ian Schofield, Pink Sheet) ...The pre-election manifestos published by the three biggest UK political parties – the Conservatives, Labour and the Liberal Democrats – include a range of ideas for encouraging innovation in life sciences and tackling the problems faced by the National Health Service. Among the pledges are a comprehensive mutual recognition agreement between the UK MHRA and the European Medicines Agency, a plan to enable "nimble and agile regulation," a clearer route for getting new drugs into the NHS, and proposals to make clinical trial set-up more efficient and accessible... Sub. Req'd

‘Persistent and Severe Misconduct' Triggers Call for Reform of UK Drug Marketing Regulation

(6/21, Nick Paul Taylor, Fierce Pharma) ..."Persistent and severe misconduct" by pharma companies in the U.K. shows the inadequacy of existing self-regulation of marketing, according to researchers who analyzed complaints from 2004 to 2021...Analyzing the U.K. data revealed repeat offenders. Self-regulatory body the PMCPA ruled 159 companies had breached the rules over the analyzed period. Twenty of the companies received sanctions in at least half of the analyzed years. The PMCPA sanctioned 10 companies in 14 or more years... Full

AIDAN Backs DTAB's Move to Look into Allow Generic Substitution in JAKs

(6/22, Pharmabiz.com) ...The All India Drug Action Network (AIDAN) has backed the Drugs Technical Advisory Board's (DTAB) move to look into allowing generic substitutions for prescription drugs in Jan Aushadhi Kendras (JAKs) stating that it would help to bust the myth that only renowned brands are of good quality. In an open letter to the Union health minister, the Network came down heavily on the opposition of Indian Pharmaceutical Alliance (IP Alliance) --the alliance of top pharma companies in the country --against the DTAB's proposal... Full

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