Thursday, May 23, 2024

Teva's Adderall Makes it Off the FDA Shortage List While Generic ADHD Med Supply Squeeze Persists

(5/22, Zoey Becker, Fierce Pharma) ...In a welcome respite from the persistent nationwide Adderall shortage, Teva seems to have gotten a handle on its supply. The drugmaker has all of its Adderall products marked as available on the FDA's shortage list, except for the 5-mg version of its generic offering, which is estimated to see supply recovery in June. The company is currently manufacturing and distributing the drugs "consistent with historic levels" but continues to see unprecedented demand, according to the FDA shortage database... Full

10 Drugs Now in Shortage

(5/22, Paige Twenter, Becker's Hospital Review) ...Here are 10 new shortages, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists...Ambrisentan tablet: Four solutions of the pulmonary arterial hypertension medication are in short supply and 12 solutions are available. Teva Pharmaceuticals' products are on back order, and the company expects supply to rebound in late May...Fluticasone propionate; salmeterol xinafoate powder: Teva discontinued three AirDuo Digihaler products in late April...Mefloquine hydrochloride tablet: One solution of the malaria therapy is in shortage, and Teva expects the supply issue to recover in August... Full

Amneal Pharmaceuticals Begins Supplying Generic Version of Narcan

(5/22, Ben Glickman, Dow Jones) ...The drugmaker said Wednesday that it was supplying its over-the-counter Naloxone Hydrochloride Nasal Spray to U.S. retail pharmacies and the state of California...Amneal said it expected to have capacity to produce about 10 million two-packs of the product annually at its New Jersey manufacturing site, starting next year. Amneal said that Naloxone Hydrochloride Nasal Spray was now available for direct distribution to states and municipalities... Full

Sanofi Drug Shows Promise in Asthma After Blood Disorder Success

(5/22, Tim Loh, Bloomberg) ...A Sanofi experimental drug showed promise in treating asthma, supporting the French drugmaker's plan to begin more late-stage studies of a medicine that it sees as a potential blockbuster. The therapy, called rilzabrutinib, helped adults better control their asthma and alleviated symptoms in a mid-stage study, Sanofi said in a statement Wednesday... Full

Phase 2 Study Demonstrates Oral Rilzabrutinib Reduces Loss of Control Events in Patients With Asthma

(5/22, Gillian McGovern, Pharmacy Times) ...Positive results from a phase 2 trial (NCT05104892) demonstrate that treatment with oral rilzabrutinib at both a high and low dose led to a numerical reduction in loss of asthma control (LOAC) events. The results were presented at the 2024 American Thoracic Society International Conference in San Diego, which was held May 17 to May 22... Full

Dr Reddy's Strikes $67M Deal With Alvotech On Denosumab

(5/22, David Wallace, Generics Bulletin) ...The announcement of the denosumab alliance comes after Alvotech in January announced positive top-line results from a pharmacokinetic study which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia in healthy adult subjects...While Alvotech has partnered with Teva on several biosimilars in the US, including approved versions of adalimumab and ustekinumab, Teva has its own in-house denosumab candidate in development. In terms of when AVT03 could launch, Dr Reddy's did not offer specifics, but indicated that "considering the expected commercialization time frame, it is expected to contribute to revenue from FY2026 onwards."... Global Sub. Full

Regeneron Narrows Bids to Block Eylea Biosimilars to One Patent

(5/22, Christopher Yasiejko, Bloomberg Law) ...Regeneron Pharmaceuticals Inc. will lean on just one of the dozens of patents behind its Eylea biologic as it seeks to block three drugmakers from selling biosimilar versions of the blockbuster drug while their infringement lawsuits continue, the company told a West Virginia federal judge... Sub. Req'd

Digesting The Legal Landscape After Landmark US Eylea Biosimilar Nods

(5/22, Dean Rudge, Generics Bulletin) ...The US Food and Drug Administration has given the green light for biosimilar competition to the near $6bn eye-disease juggernaut Eylea, but a major legal overhang is currently throttling the potential for any near-term launches. Generics Bulletin explores the lay of the land, including the recent scheduling conference in the now-consolidated trial involving five aflibercept biosimilar sponsors... Global Sub. Full

J&J Positions Tremfya as Stelara Successor with Strong Head-to-Head Data

(5/22, Tristan Manalac, BioSpace) ...Johnson & Johnson on Tuesday unveiled early Phase II/III data from its GALAXI 2 and GLAXI 3 studies, showing that its IL-23 blocker Tremfya (guselkumab) outperformed its blockbuster antibody Stelara (ustekinumab) in the treatment of moderately to severely active Crohn's disease...In an effort to keep its grip on the market, J&J has been striking a series of deals to fend off biosimilar competition. Last month, Teva and Alvotech won the FDA's approval for their copycat Selarsdi (astekinumab-aekn) but will not be able to launch the product earlier than Feb. 21, 2025, per a June 2023 settlement agreement with J&J... Full

Hikma Delivers On Expansion Plans With Move Into Spain

(5/23, David Wallace, Generics Bulletin) ...Hikma has delivered on years-long plans by entering Spain's generic injectables market, strengthening its European presence with the establishment of a Spanish subsidiary, Hikma España. Citing a local generic injectables market that was worth around $860m, the firm noted that it was "already supporting the Spanish hospitals by providing key oncological molecules that are currently in shortage." So far in 2024, "Hikma has received 36 product approvals and launched 25 products in Spain," the firm indicated. "These span several therapeutic areas including cardiovascular, oncology, central nervous system and anti-infectives."... Global Sub. Full

Celltrion Eyes M&A in Europe, $3.3 Bn Zymfentra Sales: Chairman

(5/23, Hyun-Ah Oh and Dae-Kyu Ahn, The Korea Economic Daily) ...We are pursuing an M&A with one of famous pharma companies in Europe. If the negotiation is successful, we will disclose its name within this year," Celltrion Group founder and Chairman Seo Jung-jin said in an interview with The Korea Economic Daily at Digestive Disease Week 2024 on Tuesday (local time). "But there is a hurdle, approval from the related local authorities (for the deal), which we must secure first."...Celltrion's takeover attempt in Europe comes as another deal to acquire a major Japanese pharmaceutical company is in limbo due to the Japanese authorities' reluctance to let a Korean company own a Japanese company, the chairman said... Full

Pfizer Rolls Out Another Cost-Cutting Program, Sets $1.5 Billion Target by 2027

(5/23, Michael Erman and Bhanvi Satija, Reuters) ...U.S. drugmaker Pfizer on Wednesday launched a new multi-year program to reduce its expenses by about $1.5 billion by the end of 2027, adding on to a $4 billion cost cutting plan it announced last year...The focus will be on "operational efficiencies, network structure changes, and product portfolio enhancements," the company said. Pfizer said that the program will take multiple years because of the complexity in manufacturing and longer lead times required to make changes... Full

Biogen in Up to $1.8 Bln Deal as Rare Diseases Take Center Stage

(5/22, Manas Mishra and Sriparna Roy, Reuters) ...Biogen said on Wednesday it had agreed to buy privately held Human Immunology Biosciences for up to $1.8 billion, bulking up on rare disease medicines as its older multiple sclerosis drugs face tepid demand due to rising competition... Full

Lupin Shares Fall 7% After Second Largest US Contributor Drug Faces More Competition

(5/23, Ekta Batra, Vivek Lyer and Meghna Sen, CNBC TV 18) ...Shares of pharmaceutical companies Lupin Ltd. and Cipla Ltd. are witnessing profit booking on Thursday. The stocks declined up to 7%, bogged down by an increased competition in Albuterol Sulfate Inhalation Aerosol in the US...According to IQVIA, the US sales for the branded and generic albuterol sulfate Inhalation Aerosol products were approximately $1.7 billion for the 12 months that ended March 31, 2024. The new player is expected to resort up to 10-25% price erosion to gain market share... Full

Xbrane Welcomes Milestone In $14Bn Nivolumab Journey, Partner Sought

(5/23, Dean Rudge, Generics Bulletin) ...Manufacturing for Xbrane Biopharma's proposed biosimilar to Bristol Myers Squibb's Opdivo (nivolumab) is now taking place at the scale required for future commercialization and clinical trials, the Swedish firm has revealed, as it laid out plans to wrap up a partnership for its proposed immuno-oncology PD-1 inhibitor biosimilar, Xdivane, later this year. Xbrane says its achievement is the result of an investment set to reach $25m by the end of 2024, putting it on a path to produce nivolumab clinical material this year and move forward with clinical trials – potentially – in the first half of 2025... Global Sub. Full

Hospitals Grapple with Generic Drug Supply Shortages

(5/22, Ayla Ellison, Dave Muoio, Fierce Healthcare) ...Fierce Healthcare's Dave Muoio sat down with Allan Coukell, policy head at the hospital-backed nonprofit drug supplier Civica Rx. Coukell sheds light on how these shortages are impacting healthcare providers' care and purchasing practices. He also provides insight into recent administration strategies aimed at bolstering drug supply chain resilience and offers immediate advice to organizations navigating these challenging shortages... Full

Drug Prices and Shortages Jeopardize Patient Access to Quality Hospital Care

(5/22, Bharath Krishnamurthy and Megha Parikh, American Hospital Association) ...In a recent AHA report, we highlighted the range of cost-related challenges that hospitals and health systems continue to face that have created sustained headwinds for the field. These cost-related challenges include labor, medical supplies and administrative costs related to dealing with private insurance denials and prior authorizations. But of particular concern is the alarming and worsening three-part trend of rising prices for existing drugs, new drugs being introduced at record-high prices and shortages for many critical drugs... Full

Drug Shortages, Cost Concerns and Iffy Access — How DTC and Telehealth Could Even the Playing Field

(5/22, Michael Gibney, PharmaVoice) ...A combination of telemedicine and DTC drug sales could more directly connect patients to the supply chain, helping to resolve drug shortages and potentially drive down out-of-pocket costs, said Peter Ax, CEO of UpScriptHealth, a telehealth company that got an early start on the idea by writing the first legally compliant online prescription in 2002. Ax sees the potential for DTC drug sales to upend opaque "oligopolies" in the current system run by pharmacy benefit managers for branded treatments and hospital purchasers for generics... Full

Real-World Data Show Impact of Popular Movement Disorder Drug

(5/22, The Pharma Letter) ...The Journal of Clinical Psychopharmacology has published a post hoc analysis of data from the Phase III KINECT-4 study of Ingrezza (valbenazine). Developed by Neurocrine Biosciences, Ingrezza is the only once-daily selective VMAT2 inhibitor approved for people with tardive dyskinesia and the treatment of chorea associated with Huntington's disease...The product has been commercially successful, generating $1.84 billion in revenues in 2023, a significant increase from the previous year. For 2024, the company has projected Ingrezza's revenue to be between $2.1 billion and $2.2 billion, with competition coming primarily from Teva Pharmaceutical's Austedo (deutetrabenazine)... Sub. Req'd

World Asthma Awareness Month | Why Public Awareness is Vital in Paediatric Asthma Management

(5/22, Achin Gupta, CNBC TV 18) ...Since this year's theme for World Asthma Awareness Month (May) — "Asthma Education Empowers" — holds significant relevance given India's current respiratory health challenges, Cipla's One India Business CEO Achin Gupta shares his views on the vital need of public awareness about the disease and its management in the country's specific context... Full

ADHD Diagnoses Are Rising. 1 in 9 U.S. Kids Have Gotten One, New Study Finds

(5/23, Maria Godoy, NPR) ...About 1 in 9 children in the U.S., between the ages of 3 and 17, have been diagnosed with ADHD. That's according to a new report from the Centers for Disease Control and Prevention that calls attention-deficit/hyperactivity disorder an "expanding public health concern." Researchers found that in 2022, 7.1 million kids and adolescents in the U.S. had received an ADHD diagnosis – a million more children than in 2016. That jump in diagnoses was not surprising, given that the data was collected during the pandemic, says Melissa Danielson, a statistician with the CDC's National Center on Birth Defects and Developmental Disabilities and the study's lead author... Full

Starting ADHD Meds in Adulthood May Increase Risk of Heart Disease, Study Says

(5/22, Mallika Marshall, MD, CBS News) ...A new study finds adults who start taking ADHD medications may be at higher risk of heart disease and stroke. It's estimated that up to 5% of U.S. adults have the condition, but a new study in the Journal of the American College of Cardiology suggests that those taking medication for the first time may have an elevated heart risk... Full

US Senators Accuse Pharma Firms of Abusing Patent System

(5/22, Phil Taylor, Pharma Phorum) ...In their sights are strategies that are claimed to game the patent system to extend monopolies and block lower-cost generic and biosimilar drugs from entering the US market. Senate Majority Whip Dick Durbin (D-IL), who chairs the committee, said in an opening statement to the hearing that in 2022 drug manufacturers raised the prices of more than 1,200 medicines by an average of 32%, four times the rate of inflation... Full

NIH Drug Patent Licensees Would Develop ‘Access Plan' Under Proposal; Pricing Commitments Optional

(5/22, Cathy Kelly, Pink Sheet) ...The National Institutes of Health is proposing to help enhance public access to drugs, biologics, vaccines and medical device products stemming from taxpayer-funded inventions by requiring that patent licensing arrangements made through its Intramural Research Program include a plan to achieve that goal. The plan could, but would not be required to, include ways to ensure affordability through pricing commitments, according to the proposed rule published on May 22... Sub. Req'd

Skinny Is As Skinny Does – At Least When it Comes to Labeling Carve-Outs

(5/22, Bob Pollock, Lachman Consultants) ...The AAM letter explains in detail the problem and "supports the statutory safe harbor for carve-outs proposed by the Food and Drug Administration in its fiscal year (FY) 2024 budget and urges its adoption." The letter notes that "[D]espite this well-established practice, a recent decision from the U.S. Court of Appeals for the Federal Circuit threatens to undermine Hatch-Waxman's carve-out process. That decision, GSK v. Teva, holds that a generic can be liable for infringing the brand's patented method that the generic carved-out from its label, based on arguments that the carve-out was supposedly not broad enough, and that the generic publicly described its product as the equivalent of the brand product—something that is true of every generic... Full

Federal Appeals Court Sides with Drugmakers On 340B Limitations

(5/22, Nicole DeFeudis, Endpoints News) ...A federal appeals court ruled on Tuesday that drugmakers are not restricted from setting contractual limits on the distribution of discounted drugs under a federal drug discount program known as 340B...The pharmaceutical industry's DC-based lobbying group praised the decision on Wednesday. Deputy VP of public affairs Nicole Longo said in a statement that it "further underscores the need for Congress to comprehensively fix the 340B program and ensure it works to lower costs for vulnerable patients."... Full

Second Appeals Court Rules Drug Makers Can Impose 340B Restrictions

(5/22, Gabrielle Wanneh, InsideHealthPolicy) ...The appeals court ruled that the separate conditions Novartis and United Therapeutics have placed on how many and what kinds of contract pharmacies 340B hospitals can use to dispense discounted drugs to patients are not in violation of the statute at face value, even though the law doesn't explicitly state that they can or cannot impose such restrictions...Nicole Longo, spokesperson for the Pharmaceutical Research and Manufacturers of America, told Inside Drug Pricing that the brand drug lobby is pleased with the DC circuit court's favorable ruling for drug makers, and that Congress needs to permanently fix the 340B law... Sub. Req'd

CDER, CBER Heads Avoid Weighing In On IRA Innovation Impacts

(5/22, Jessica Karins, InsideHealthPolicy) ...While emphasizing FDA's support for innovative drug development, the directors of FDA's drugs and biologics centers declined to comment on how the Inflation Reduction Act's Medicare drug price negotiation program could impact investment in drug research and development, when asked by House lawmakers Wednesday (May 22) for their take on recent remarks by a high-level biologics official that the law is deterring some investment... Sub. Req'd

IRA’s Medicare Impact: Beware This Faustian Deal

(5/22, Seth J. Baum, RealClearHealth) ...This calculus is made more difficult by the way the IRA bifurcates medicines into two categories: biologics, injectable or infused therapies, and small molecules, typically pills and other oral drugs. The law says that small molecule medicines can be selected for price negotiation after only nine years on the market. Injected therapies, however, have been granted a reprieve of four additional years before being subject to Medicare negotiation. That’s a huge economic incentive to move research away from the small molecule therapies, regardless of the potential adverse scientific or medical ramifications... Full

Why the IRA Will Encourage Part D Plans to Prefer High-List, High-Rebate Drugs (Video)

(5/22, Adam J. Fein, Ph.D., Drug Channels) ...In the video excerpt below, I walk through a mathematical example to show why the IRA will encourage Part D plans to prefer high-list, high-rebate specialty drugs, even as the government and manufacturers will prefer a low-list-price version. What's more, a product with a maximum fair price may also raise total costs for the healthcare system—despite the likely political posturing and spin... Full

US Pharma and Biotech Summit 2024: Improving Health Policy After the 2024 Election

(5/22, Don Tracy, PharmExec.com) ...In an interview with Pharm Exec Associate Editor Don Tracy, Robert Zirkelback, Chief Public Affairs Officer, Head of Strategic Initiatives, PhRMA discusses best-case scenarios for health policy amid the 2024 presidential election... Full

Biosimilars Account for 23% Market Share, With Wide Uptake Disparities Across Molecules

(5/22, Skylar Jeremias, The Center For Biosimilars) ...Despite contributing significantly to reduced drug costs and market growth, biosimilars account for only about 23% of the overall biologics market, showing wide variation in uptake across different molecules, according to the IQVIA Use of Medicines in the US report... Full

It's Time for Over-the-Counter Ozempic

(5/22, Charles M. Silver, Jeffrey A. Singer and Michael F. Cannon, Reason) ...The FDA doesn't need to increase prices further by encouraging unnecessary insurance coverage for these drugs. President Joe Biden says he wants to reduce drug prices. The promise of semaglutide and tirzepatide presents an opportunity to do that. The FDA need only leave consumers free to buy these medicines OTC... Full

New Bill Aims To Limit ‘Revolving Door' Between FDA And Industry

(5/22, Jessica Karins, InsideHealthPolicy) ...High-level officials at FDA along with the Centers for Disease Control and Prevention and the National Institute of Health would be barred from working in regulated industry for eight years, in addition to other new ethical requirements aiming to limit the "revolving door" between companies and federal agencies, under recently introduced legislation... Sub. Req'd

House Committee Presses FDA Center Directors On Domestic Manufacturing, LDTs

(5/22, Lia DeGroot, Endpoints News) ...The House Energy & Commerce's subcommittee on health heard from the directors of the FDA's device, biologics and drug centers on Wednesday for a "check up." Representatives peppered the officials on topics ranging from generic drug manufacturing to the agency's new rule on lab-developed tests... Full

FDA's Marks, Woodcock Talk Regulatory Flexibility for New Rare Disease Drugs

(5/22, Lia DeGroot, Endpoints News) ...Peter Marks, the FDA's biologics center director, and Janet Woodcock, former FDA deputy commissioner who retired earlier this year, discussed how the agency should be able to balance following regulations with exercising some flexibility for rare diseases. "What we've seen is a lot of cognitive dissonance internally," Woodcock said. "People are being asked to, on one hand, enforce the standard, on the other hand be flexible. You can be flexible, flexible, flexible, and then pretty soon, you're going to break."... Full

Woodcock Nostalgia: GOP Rep. Bilirakis Wants CDER To Recapture Her Flexible Approach

(5/22, Derrick Gingery, Pink Sheet) ...House Republicans called for increased use of accelerated approval for rare disease treatments. Rep. Gus Bilirakis encouraged CDER Director Patrizia Cavazzoni to embrace Janet Woodcock's approach to the tool. Bilirakis also praised CBER for its use of regulatory flexibility and suggested the biologics center was more flexible than CDER... Sub. Req'd

A Kentucky Congressman is Working to Reduce Prescription Costs, Make Health Care Affordable

(5/23, Stephanie Wright, Courier Journal) ...[U.S. Rep. James Comer, a Kentucky Republican], who chairs the House of Representatives' Oversight Committee, continues to hold hearings to get to the bottom of why our prescription drugs have become so expensive. Everyone in this area understands how significant this issue is. For instance, a 2020 survey revealed that three out of four Kentuckians struggle with health care affordability, with many having to choose between paying for their medications or other basic necessities... Full

Major Boost For WHO-Listed Authority Scheme As US & EU Regulators Designated

(5/22, Eliza Slawther, Pink Sheet) ...The US Food and Drug Administration and the European medicines regulatory network, which includes the European Commission, the European Medicines Agency and 30 national agencies, are now WHO-Listed Authorities under a framework launched in 2022...Both the FDA and the EMA expressed their strong support for the new framework in statements to the Pink Sheet. An EMA spokesperson said that being part of the WLA initiative "supports industry's confidence in our evaluations when seeking approval in other regions."... Sub. Req'd

EXPLAINER | Pharma Exports: Quality Issue in Made-in-India Drugs

(5/23, Manu Kaushik, Financial Express) ...In 2022 and 2023, World Health Organisation and other regional authorities had issued alerts after several contaminated cough syrups manufactured in India were linked to the deaths of 78 children in Uzbekistan and Gambia. Recently, the apex drug regulatory body withdrew the power of state licensing authorities to issue clearances to export-only drug manufacturing units. Manu Kaushik explains how this step can bring domestic manufacturing practices in line with global standards... Full

Health Ministry Panel Urges Consolidation in Japan's Drug Sector

(5/23, Yukana Inoue, The Japan Times) ...A health ministry panel is urging small drugmakers to merge with their bigger counterparts to ensure a stable supply of generic drugs in Japan amid an ongoing shortage. In making the call in a report released on Wednesday, the panel noted that the inefficiency of the present situation, in which each company produces small quantities of a wide range of products stemming from a background of many drugmakers entering the generic drug market all at once... Full

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