Thursday, February 1, 2024

Teva Pharma CEO Richard Francis On Q4 Earnings

(1/31, CNBC) ...Richard Francis, Teva Pharmaceuticals CEO, joins ‘Money Movers' to discuss the company's recent divestiture, how easy it'll be to disentangle from part of its business, and more... Full

How Teva's CEO is Implementing His 'Pivot to Growth' Strategy

(1/31, Rachelle Akuffo, Yahoo! Finance) ...Teva CEO Richard Francis joins Yahoo Finance Live alongside Health Reporter Anjalee Khemlani to discuss the latest quarterly earnings report and plans for the company moving forward. Francis comments on his pivot to growth strategy: "When I came in and we did the pivot-to-growth strategy, we looked across all the businesses at Teva. We understood, where did we want to grow? We clearly want to grow our innovative business and our generics business... The API business, TAPI, its the second largest API manufacturer in the world, it is world class. But two things we saw and analyzed it, which is, one, it's constrained being part of Teva. The global API market is an $85 billion market..."... Full

Teva's Refresh Under New CEO Richard Francis Moves into Year 2 As Austedo, Ajovy and Generics Gain Steam

(1/31, Fraiser Kansteiner, Fierce Pharma) ...After charting a series of sales increases in 2023, Teva's largely made good on the promise of its new CEO's "Pivot to Growth" campaign. With group revenues on the up and up, it's all about maintaining momentum in the years to come, the company's chief executive Richard Francis said in an interview...While the plan hinges on innovative drugs like Austedo, Ajovy and Teva's new long-acting schizophrenia med Uzedy, copycat pharmaceuticals still have an important role to play in Francis' vision for the company, the CEO explained... Full

In Continuing its Transformation, Teva Confirms Plan to Sell Off API Business

(1/31, Kevin Dunleavy, Fierce Pharma) ...Teva's transformation under new CEO Richard Francis is taking another turn. Wednesday, the company confirmed plans to sell its active pharmaceutical ingredients business as part of Francis' "pivot to growth" strategy...Selling off its API business would be a major step in moving away from generics, as well as following an industry trend in which companies are separating from their less profitable business sectors to concentrate on those with the greatest return... Full

Teva Plans to Divest Drug Ingredients Business in Next Step of Strategic Shift

(1/31, Josh Nathan-Kazis, Barron's) ..."No one's talking about debt, or opioids or even Humira…because there's so many other good things that are happening in this company," Teva CEO Richard Francis told Barron's listing three key worries that dogged the stock a year ago...Francis acknowledged that the strategic shifts he has undertaken at Teva have changed the nature of the company, which has historically specialized in generic drugs. "Teva should be considered a pharmaceutical company that has a world-class generics business, but also a fast-growing innovative [medicines] business," Francis said... Full

Teva Plans Sale of API Unit Amid 'Pivot to Growth'

(1/31, Nicole DeFeudis, Endpoints News) ...The move will allow Teva to focus on its generics and innovative portfolio, CEO Richard Francis told investors on the company's fourth-quarter earnings call. Teva has made clear that it wants to move beyond its reputation as a generics giant, which will involve cutting some low-margin generics already being supplied by other manufacturers and being more selective about which new generics it pursues, Francis told Endpoints News earlier this month at the JP Morgan Healthcare Conference... Full

Teva, GSK Put Up Bullish Fourth-Quarter Performances. Here's Where Novartis Fell Short.

(1/31, Allison Gatlin, Investor's Business Daily) ...Teva stock neared a profit-taking zone Wednesday, while GSK stock — a fellow pharma Goliath — bounded briefly out of a chase zone on strong fourth-quarter performances for both. The strong showing from Teva Pharmaceutical came on the back of Austedo, a treatment for involuntary movements caused by tardive dyskinesia or Huntington's disease. Austedo sales surged 18% to $408 million, beating forecasts for $401.7 million, according to FactSet... Full

Teva Price Target Raised to $16 from $15 at UBS

(2/1, The Fly) ...UBS analyst Ashwani Verma raised the firm's price target on Teva to $16 from $15 and keeps a Buy rating on the shares. The firm has further conviction in its bull thesis post-Q4, and sees the improving base business growth narrative driving upside in the first half of the year, while Teva's pipeline can drive outperformance in the second half, the analyst tells investors in a research note... Full

USP And Dexcel Pick Up Teva OTC Brands

(1/31, Tom Gallen and David Ridley, Generics Bulletin) ...Teva has struck a deal with USP in Poland that will see the Israeli company divest multiple consumer health brands. Meanwhile, Dexcel Pharma has acquired eight OTC brands from Teva in the UK...Teva confirmed that it had completed the divestment of both brands to USP. "In line with the new pivot to growth strategy, Teva is now focusing globally on research and development of its global portfolio, increasing innovation and further strengthening its presence in the generic medicines market," the Israel-based firm commented... Global Sub. Full

MedinCell's Partner Teva Provides Guidance for UZEDY in 2024 and An Update On The Treatment-Candidate of Olanzapine Long-Acting Injectable (LAI)

(1/31, MedinCell) ...During the Q4 2023 earnings call held today by Teva Pharmaceutical Industries Ltd., President and CEO Richard Francis stated that he expects a strong uptake and significant growth for UZEDY in 2024. He notably provided the annual revenue guidance for UZEDY, projecting approximately $80 million for 2024...Eric Hughes, Executive Vice President, Global R&D & Chief Medical Officer, announced during the call that 62% of the targeted 3,600 injections have already been performed as part of the ongoing Phase 3 clinical trial and that no PDSS has been observed. Full clinical package on efficiency and safety is expected in the second half of 2024... Full

 

Pharma Companies Lose Fight Over Venue for States' Price-Fixing Lawsuits

(1/31, Mike Scarcella, Reuters) ...Dozens of drug makers have lost their bid to keep a group of price-fixing lawsuits joined together in Pennsylvania federal court, after a court panel on Wednesday said Connecticut and other state plaintiffs could press their own cases separately...Drug makers Teva, Sandoz, Aurobindo and others had urged the judicial panel not to let Connecticut and its state coalition break away, warning it would cause "chaos" in the litigation. They argued that they should not be forced to fight the same claims in different federal courts before separate judges... Full

V.I. Reaches Agreement as Part of National $2.7 Billion Opioid Settlement

(1/31, Sian Cobb, The St. Thomas Source US Virgin Islands) ...The V.I. Attorney General's Office has signed on to a $2.7 billion nationwide settlement agreement with companies Allergan and Teva Pharmaceuticals over the opioid epidemic...In reaching the settlement, neither Allergan nor Teva admitted any wrongdoing. Both companies and their subsidiaries were included in the suit because Teva bought Allergan's generic drug business in 2016 for roughly $40 billion... Full

Sanofi Q4 Earnings Hit by Weak Dollar, Generic Competition

(2/1, Ludwig Burger, Reuters) ...Sanofi's fourth-quarter operating income fell 5% as a weaker U.S. dollar and cheap competition to multiple sclerosis drug Aubagio outweighed rising sales of anti-inflammatory drug Dupixent...CEO Paul Hudson has been trying to build investor confidence in Sanofi's drug pipeline since he unexpectedly abandoned 2025 margin targets last October to instead boost drug development spending, causing a 15% plunge in the share price... Full

‘Watch This Evolve': Sanofi Continues to Talk Up its R&D Bet as Paul Hudson Welcomes New CFO

(2/1, Amber Tong, Endpoints News) ...As Sanofi CEO Paul Hudson embarks on a two-year mission to cut and reallocate up to €2 billion ($2.16 billion) in costs, he will be leaning on a new chief financial officer. Jean-Baptiste Chasseloup de Chatillon is stepping down after five years. Replacing him as CFO beginning on April 1 will be François-Xavier Roger, the former CFO of Takeda who spent the past eight years at Nestle. According to Sanofi, de Chatillon is leaving to take up charity work full-time as the head of an adolescent-focused foundation named Apprentis d'Auteuil... Full

India's Mankind Pharma Beats Q3 Profit Estimates On Strong Demand

(1/31, Kashish Tandon, Reuters) ...Mankind Pharma, one of India's leading condom makers, posted a bigger-than-expected rise in third-quarter profit on Wednesday, driven by strong domestic sales, especially in the company's chronic drugs segment. The country's fourth-largest pharmaceutical company by domestic sales said its consolidated profit rose 60% to 4.54 billion rupees (nearly $55 million) for the October-December quarter, beating analysts' average estimate of 4.29 billion rupees, as per LSEG data... Full

Roche Sees Pick Up in Growth as it Overcomes Drop in COVID Sales

(2/1, Maggie Fick and Ludwig Burger, Reuters) ...Roche forecast a pick up in sales growth this year as it overcomes a slump in demand for its COVID-19 products and a decline in sales of a trio of established cancer drugs abates. The Swiss drugs and diagnostic maker said on Thursday that group sales, which include diagnostics, would grow by a mid-single digit percentage, when adjusted for currency swings... Full

GSK Confirms Arexvy is a Blockbuster But Says the RSV Battle Has Just Begun

(1/31, Kevin Dunleavy, Fierce Pharma) ...Wednesday, when GSK reported its quarterly and annual earnings, it confirmed that Arexvy was blockbuster in its first year on the market. And it took the company just two quarters—or "four months" as CEO Emma Walmsley was quick to point out during a conference call—to accomplish the feat as Arexvy generated sales of 1.2 billion pounds sterling ($1.5 billion). Making the achievement that much more satisfying for the British pharma major is that it stared down a challenge from Pfizer. A day earlier, Pfizer reported 2023 sales of its RSV vaccine Abrysvo at $890 million... Full

Merck Results Beat Expectations As Top Drugs Keytruda, Gardasil Post Strong Sales

(2/1, Annika Kim Constantino, CNBC TV 18) ...Merck on Thursday reported fourth-quarter revenue and adjusted earnings that topped estimates as it saw strong demand for its blockbuster cancer drug Keytruda and HPV vaccine Gardasil. The pharmaceutical giant posted a net quarterly loss, however, due to previously announced charges associated with a deal the company struck in October with the Japanese drugmaker Daiichi Sankyo to co-develop three highly sought-after cancer treatments... Full

Takeda Pharmaceutical's Third-Quarter Net Profit Dropped on Lower Margins

(2/1, Kosaku Narioka, The Wall Street Journal) ...Takeda Pharmaceutical reported a drop in its third-quarter net profit due partly to lower margins despite some growth in revenue. The Japanese drugmaker said Thursday that net profit decreased 11% from a year earlier to 105.7 billion yen ($719.3 million) for the three months ended Dec. 31. That beat the estimate of Y78.165 billion in a poll of analysts by data provider Quick... Sub. Req'd

Biogen Will Stop Selling Its Controversial Alzheimer's Drug Aduhelm

(1/31, Tom Murphy, Associated Press) ...Biogen will stop selling its Alzheimer's treatment Aduhelm, a drug once seen as a potential blockbuster that stumbled after its launch a few years ago. The drugmaker also said Wednesday that it will end a study of the drug needed for full approval from the Food and Drug Administration...Biogen said it will turn its focus to other treatments for the fatal, mind-robbing disease. The company also is helping Japanese drugmaker Eisai sell another Alzheimer's treatment, Leqembi, which received full FDA approval last summer... Full

Cencora Raises Profit Outlook On Robust Demand for High-Priced Specialty Drugs

(1/31, Mariam Sunny, Reuters) ...Drug distributor Cencora raised its annual profit outlook on Wednesday, betting on strong demand for costly specialty medicines that treat diseases such as cancer and rheumatoid arthritis. The Pennsylvania-headquartered company also beat first-quarter profit and revenue estimates, sending shares up nearly 3% in premarket trading... Full

Samsung Bioepis, Samil Pharm to Co-Market Eylea Biosimilar

(2/1, Lee Han-soo, Korea Biomedical Review) ...Samsung Bioepis and Samil Pharmaceutical have announced a marketing partnership for the local sales of SB15, a biosimilar referencing Eylea..."Through this agreement, we will further enhance the synergy between our R&D capabilities and Samil Pharmaceutical's sales and marketing expertise," Samsung Bioepis CEO Ko Han-sung said. "We will strive to provide more domestic patients with ophthalmic diseases with treatment opportunities through high-quality biopharmaceuticals."... Full

Sandoz Rolls Out Natalizumab Biosimilar In Germany

(1/31, David Wallace, Generics Bulletin) ...Sandoz is rolling out its Tyruko natalizumab biosimilar rival to Biogen's Tysabri in Germany, heralding the product as the "first and only biosimilar for multiple sclerosis."...Having received European Commission approval for Tyruko last year, Sandoz had told Generics Bulletin that the company planned to launch the biosimilar "progressively across Europe, on a country-by-country basis, from Q4 2023 onwards." However, in terms of the specifics of the roll-out, the firm had said in September that "we would not comment at this stage on launch sequence."... Global Sub. Full

Glenmark Partners with Pfizer to Launch Abrocitinib in India to Treat Atopic Dermatitis

(1/31, The Economic Times) ...Glenmark on Wednesday said it has partnered with Pfizer to launch abrocitinib in India used for treatment of moderate-to-severe atopic dermatitis. Glenmark and Pfizer will co-market abrocitinib in India under the brand names JABRYUS and CIBINQO. Developed by Pfizer, abrocitinib has received marketing authorization for abrocitinib in adults with moderate-to-severe atopic dermatitis from the Central Drugs Standard Control Organization... Full

GSK Settles Another Zantac Lawsuit in California

(2/1, Eva Mathews, Reuters) ...GSK said on Thursday it had agreed to settle another lawsuit in California that alleged its discontinued heartburn drug Zantac caused cancer, the latest in a series of settlements to end costly litigation. The case was set to go to trial on Feb. 20 and instead, will now be dismissed, the British drugmaker said in a statement. GSK said the terms of the settlement were confidential and that it did not admit to any liability... Full

Aurobindo Pharma Confirms CNBC-TV18 Newsbreak, Says Inspection Ongoing at Unit 4

(2/1, Ekta Batra, CNBC TV 18) ...Drugmaker Aurobindo Pharma Ltd. responded to CNBC-TV18's exclusive newsbreak, stating that the USFDA inspection of Eugia-III, the erstwhile Unit IV of Aurobindo Pharma, the formulation manufacturing facility of Eugia, is under progress from January 22..."As per the usual and standard practice, after the inspection is concluded, Aurobindo Pharma intimates the stock exchanges regarding the outcome, including the number of observations, if any, and the same will be followed for the ongoing inspection also," the company said... Full

Happy Birthday Adalimumab Biosimilars: Reflecting on the First Year of US Competition

(1/31, Skylar Jeremias, The Center For Biosimilars) ...With 9 adalimumab biosimilars launching throughout the year, the US rheumatology, immunology, dermatology, and gastroenterology treatment spaces have a wealth of newer and cheaper alternatives to Humira (reference adalimumab)...To mark this momentous occasion, The Center for Biosimilars® takes a walk down memory lane to reflect on how this space has developed over the last year, including all the major launches and approvals, new pricing strategies, and market trends that have come to differentiate the adalimumab biosimilar space from other markets... Full

Time To Tip the Scales? Humira Biosimilars And The Limitations Of Competition In US Health Care

(1/31, Sarah Karlin-Smith and Jinghong Chen, Pink Sheet) ...Humira's continued strong formulary position in its second year facing biosimilar competition is discouraging health policy experts and generic executives alike about the prospects for future biosimilar launches. Pending PBM reform legislation in the US Congress isn't likely to shift the current rebating dynamics. But Part D cost-sharing changes slated for 2025, as well as recent moves by Kaiser and CVS, suggest the biosimilar market may eventually gain some traction... Sub. Req'd

What's Next? Five Things To Look Out For In February

(2/1, Dean Rudge, Generics Bulletin) ...Alvotech has the chance – finally – to put its US biosimilar adalimumab demons to bed this month...FDA approval of the adalimumab biosimilar is now anticipated by Alvotech on February 24, 2024. Approval for the ustekinumab biosimilar could follow on April 16, 2024. Alvotech and its US marketing partner Teva have for some time been seeking approval for their proposed AVT02 100mg/ml adalimumab biosimilar, including with a designation for interchangeability... Global Sub. Full

U.S. Makes Initial Offers in Medicare Drug Price Negotiations

(2/1, Noah Weiland, The New York Times) ...The Biden administration announced on Thursday that it was sending initial offers to the makers of the first 10 prescription drugs that have been selected for price negotiations with Medicare under a landmark federal program intended to reduce drug spending... Sub. Req'd

Biden Administration Makes Opening Offers in Medicare Drug Price Negotiations

(2/1, Rachel Cohrs, STAT Plus) ...The offers will not be made public unless a manufacturer chooses to publicly disclose information about the talks, a senior administration official said. Companies have until March 2 to either accept the government's offer or propose a counteroffer. The Biden administration will publish the final prices by Sept. 1 of this year after the negotiation process ends...Novo Nordisk said the information provided by Medicare is "confidential," and that the company intends to evaluate the initial offer. A spokesperson for Novartis said the company isn't planning to share Medicare's offer... Sub. Req'd

Medicare Begins Drug Price Negotiation Period Amid Lawsuits

(2/1, Ian Lopez and Nyah Phengsitthy, Bloomberg Law) ...The Feb. 1 deadline marks the beginning of the negotiation period for drugmakers and the Centers for Medicare and Medicaid Services in the government's Medicare Drug Price Negotiation Program. The plan is authorized by the 2022 Inflation Reduction Act and allows the government to set prices on some of the costliest drugs Medicare covers. Companies will have 30 days to respond to the offer by either accepting or making a counter offer... Full

Medicare Drug Price Negotiations Kick Off With Price Offers On These 10 Drugs

(2/1, Ken Alltucker, USA Today) ...The Pharmaceutical Research and Manufacturers of America, a trade group representing drug manufacturers, has argued the federal efforts to implement price negotiations have lacked transparency, discounted patients' input and could reduce drug industry investments to research life-saving cures. "This continues to be an exercise to win political points on the campaign trail rather than do what's in the best interest of patients," said Alex Schriver, a senior vice president of public affairs at PhRMA... Full

Judge Skeptical of Arguments Against Medicare Drug Price Negotiation

(1/31, John Wilkerson, STAT Plus) ...AstraZeneca's lawyers argued that Medicare's new powers amount to a taking of their property rights without due process. But Colm Connolly, chief judge of the U.S. District Court of Delaware, said he doesn't understand how the law deprives AstraZeneca of its property. He asked Catherine Stetson, who represents AstraZeneca, multiple times to explain what property the company would lose due to Medicare price negotiation. Stetson said it's both the patent and the drug that's subject to the patent... Sub. Req'd

Judge Signals Doubt on AstraZeneca's Harm in Drug Price Program

(1/31, Nyah Phengsitthy, Bloomberg Law) ...AstraZeneca, in response to Connolly's questioning, heavily relied on its claim that the Centers for Medicare & Medicaid Services violated the Administrative Procedure Act when it implemented the program. The drugmaker pointed to the agency's guidance and its definitions on drugs considered for the program, alleging Medicare's definition of "qualifying single source drug" will decrease the incentives to develop new drugs. The drugmaker argued the "bona fide marketing" requirement sweeps drugs into the selection process even when they have generic competition, keeping them subject to the discounted price longer... Sub. Req'd

Apocalypse or Ripple? Ahead of First Offers On Price, New Research Predicts IRA Impact On R&D Will Be Modest

(1/31, Zachary Brennan, Endpoints News) ...Ever since the Inflation Reduction Act was signed into law by President Joe Biden in August 2022, biopharma companies have leveled attacks on it, arguing the negotiations could be nothing more than glorified price setting that will reduce R&D spending. But new research published Wednesday in Nature Biotechnology claims the IRA's hit to overall industry revenue "will be modest," and it "will not affect most top-selling drugs and will not likely result in large-scale defunding" of R&D... Full

Innovation is The Only Defence Against Drug Price Crackdown

(2/1, Financial Times) ...The first round of formal drug price negotiations — enabled by the 2022 Inflation Reduction Act — kicks off this week. The haggling concerns 10 treatments, including cancer, stroke and diabetes medications, which together cost Medicare some $50bn a year. Price cuts will be revealed in September, assuming lawsuits brought by manufacturers do not derail the programme. The impact could be significant for companies such as Bristol Myers Squibb. Its blood thinner Eliquis is expected to account for more than a quarter of sales in 2026, according to Visible Alpha... Full

PhRMA CEO: Medicare Price Negotiations are a ‘Black Box'

(1/31, McKenzie Beard, The Washington Post) ...Tomorrow is the deadline for Medicare to send initial offers to manufacturers of the 10 prescription drugs selected for the first round of price negotiations. The companies have 30 days to accept or make a counteroffer...Last week, I chatted with Stephen Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, about Medicare negotiations and what he thinks the feds should target instead to curb costs at the pharmacy counter... Full

The Challenge for Medicare Drug Negotiators: How to Value a Medicine's Benefits

(2/1, Caitlin Owens, Axios) ...New Medicare drug pricing negotiations, which kick into high gear Thursday, for the first time will allow the federal government to tie a medicine's price to how well it works compared with similar treatments...If the government decides to lean heavily into a value-based approach, it will have a series of complicated decisions to make. "One of the things that really is important here is what you're comparing to...because that can make the math look really different," said Stacie Dusetzina, a professor at Vanderbilt University School of Medicine who studies drug pricing... Full

3 Charts About Medicare Drug Price Negotiations

(1/31, KFF Health News) ...This week CMS faces a deadline to submit proposed prices to manufacturers for certain drugs. These three charts explain key elements of the drug negotiations process and what it means for Medicare beneficiaries, the timetable according to which the process will unfold, and the public's views about requiring the government to negotiate drug prices... Full

Misguided March-In: The Perilous Proposal to Police Drug Prices and Its Threat to American Innovation

(2/1, Courtland Culver, RealClearHealth) ...The National Institute of Standards and Technology's recent proposal to wield the "March-In Rights" under the 1980 Bayh-Dole Act as a tool for price-fixing drugs has ignited a firestorm of debate among stakeholders in the pharmaceutical, legal, and policy-making communities. At its core, this proposal seeks to expand the scope of "March-In Rights"—originally designed to ensure public access to inventions arising from federally funded research—to include considerations of the pricing of pharmaceutical products. This approach, however, is not just a deviation from the act's original intent; it is a leap into uncharted and potentially perilous waters that unnecessarily puts the economic and innovative future of the American pharmaceutical industry at risk... Full

House Panel Backs Bill to Dispense Opioid-Reversal Drugs by Vending Machine

(1/31, Michelle Baruchman, The Atlanta Journal-Consititution) ...People experiencing an opioid-related overdose could get reversal drugs, such as naloxone, through a vending machine under a bill a House committee passed unanimously Tuesday. House Bill 1035, sponsored by Republican state Rep. Sharon Cooper of Marietta, would protect pharmacists from criminal liability for filling up the vending machines, which are planned for use on Emory University's campus and could extend to colleges across Georgia... Full

Thompson: Problematic Guidance Patterns Remain At FDA

(1/31, Jessica Karins, InsideHealthPolicy) ...In response to a new FDA report on how the agency develops and issues guidance, a key advocate for good guidance practices said FDA is continuing to make progress, but has neglected some important areas and made little progress on changing a pattern of allowing guidance documents to remain in draft form for years or decades... Sub. Req'd

'Systemic' Changes Coming to Advisory Committee Process, FDA Commissioner Says

(1/31, Zachary Brennan, Endpoints News) ...The FDA is preparing to release "systemic" changes to its advisory committee process, Commissioner Rob Califf said Wednesday, building on months of hints that a high-profile part of the drug review process might face major reforms. Califf offered few details other than saying that top leaders at the agency are still trying to reach an agreement on what changes are likely. The work is being led by Namandjé Bumpus, the FDA's chief scientist and newly named deputy commissioner, he added... Full

Senate Greenlights Bill to Permit NY to Manufacture its Own Drugs

(2/1, Amanda D'Ambrosio and Jacqueline Neber, Crain's New York Business) ...The state Senate passed the New York State Affordable Drug Manufacturing Act on Tuesday, legislation that would authorize the Department of Health to contract with private companies to manufacture its own generic drugs. The bill would allow the state to set prices for the medications it manufactures in an attempt to offer alternatives to pricey prescription medications and drive down prices... Sub. Req'd

Streamlined EU Supplementary Protection Certificate System Moves Ahead

(1/31, Pink Sheet) ...A parliamentary committee says the proposals will remove the fragmentation in the EU SPC system and bring predictability for both the innovative and generics industry. A more harmonized, predictable and less costly EU-wide system for obtaining supplementary protection certificates for medicines has moved a step closer after the European Parliament's legal affairs committee unanimously backed two draft EU regulations that will now be voted on by the full parliament... Sub. Req'd

EU Anti-Competition Crackdown Boosts Access To Affordable Drugs, Commission Finds

(1/31, Eliza Slawther, Pink Sheet) ...The European Commission and national competition authorities imposed fines exceeding €780m ($846m) in relation to 26 cases of pharmaceutical product anti-competitive practices between 2018 and 2022, a new report from the commission has revealed...The latest commission case concerning pay-for-delay agreements related to an arrangement between Cephalon and the generics manufacturer Teva. It resulted in fines totaling €60.5m, following an investigation that took nearly a decade. Teva, which now owns Cephalon, received a "package of commercial side-deals" for agreeing to halt generic competition to Provigil (modafinil) throughout the EU, the commission found... Sub. Req'd

Out With The Old, In With The New: Decoding Biosimilar Access With VPAG

(1/31, Jenna Philpott, Pharmaceutical Technology) ...Biosimilars are meant to offer savings to health systems like the UK's National Health Service, but reimbursement systems can often thwart that effect. With a reimbursement regime change with VPAG this year, the UK biosimilar sector is now waiting to see if the change might be for the better...Industry stakeholders have welcomed the successor scheme—the voluntary scheme for branded medicine, access and growth—that was implemented starting this month, but the sector is bracing for its impact on the future of biosimilars in the UK... Full

Britain's Drug Shortages Are Caused by Regulator's Failure

(1/31, The Guardian) ...News that European countries are working together to safeguard drug supplies with a stockpile of 200 critical products comes at a time when the UK is facing the increasingly bleak prospect of more regular shortages. Generic medicines – exact copies of original patented products – fulfil 80% of all prescriptions used by NHS patients. They also save the taxpayer £15bn annually via a competitive market, which has meant we have enjoyed the lowest medicine prices in Europe. However, a range of threats are undermining the resilience of the UK's generic medicine supply chain, meaning shortages are becoming much more common... Full

India Works to Build An Authentication Ecosystem to Battle Counterfeits in Pharma & Medical Devices

(2/1, Pharmabiz.com) ...India is working to build an authentication ecosystem to battle counterfeits in pharma & medical devices, said Manoj Kochar, president, Authentication Solution Providers' Association. Indian pharma has made rapid progress on one hand, but on the other hand there is the unfortunate struggle with spurious and substandard drugs. Pharmaceutical and medical devices have been for many years one of the key targets of counterfeiters, he added... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: Registration is required to access FirstWord and Generics Bulletin. Click on the links below to register. If you have any questions or issues with access, contact InfoNOW or visit InfoNOW's Industry News page for more details regarding these subscriptions.

                                                         

FirstWord Pharma Plus: Enter your work email address on the Registration page along with your contact information in order to receive access.

  

Generics Bulletin by Informa:

•      Registration: Click on "Sign In" (link on the upper right side of the page). Enter your work email address in the "username" box and press the "Tab" button on your keyboard or click out of the box. You will then be automatically logged into the Informa news resource (no password required). You may be redirected to the Account Settings page to update your contact information.                                

•       Subsequent Access: If you're not automatically logged in, click on "Sign In" (link on the upper right side of the page). Enter your work email address. You will be automatically logged in (no password is required).

•      Note: You must be on the Teva Network (in a Teva location or connected via VPN) in order to access the Informa news resources. You can toggle between the Informa news resources by clicking the news resource on the top.