Tuesday, January 2, 2024

Teva Ends 2023 As Israeli Co With Biggest Profit On Wall Street

(12/25, Shiri Habib-Valdhorn, Globes) ...Teva Pharmaceutical Industries Ltd. recorded a non-GAAP net profit of $1.76 billion in the first nine month of 2023 and according to forecasts will end the year with non-GAAP net profit of between $2.55 billion and $2.9 billion...Oppenheimer senior equity analyst Sergey Vastchenok clarifies the difference between the company with the highest profit and the company with highest profitability. "Teva has the highest revenue turnover of Israeli companies traded on Wall Street," he explains... Full

Corcept Loses Patent Spat Against Teva, Shares Tumble

(12/29, Niket Nishant, Reuters) ...A U.S. judge ruled in favor of Israel's Teva Pharmaceutical Industries in a patent infringement lawsuit brought by Corcept Therapeutics, sparking a frenzied sell-off in shares of the California-based drug developer... Full

Corcept Therapeutics Plunges After Loss in Patent Battle with Teva

(1/1, Joshua Fineman, Seeking Alpha) ...The court found that Corcept hadn't met its burden of proving induced infringement, according to a court ruling late Friday by Judge Renée Marie Bumb of the US District Court for the District of New Jersey. "ORDERED that Teva has not infringed, and that Teva's making, using, offering to sell, selling, or importing Teva's generic mifepristone product will not infringe, claims 10–13 of the '214 Patent or claims 1, 6, 7, and 9 of the '800 Patent," the judge wrote in the opinion on Friday... Full

Teva Triumphs Over Corcept Therapeutics in Patent Lawsuit: Shares Plunge

(12/29, Bijay Laxmi, BNN) ...Teva Pharmaceutical Industries had been in the limelight for its intention to commercialize a generic version of Korlym. This move was sanctioned by the FDA in 2020, but the product has yet to see the light of day. The recent court ruling concluded that Corcept Therapeutics was unable to demonstrate a probable likelihood of Teva directly infringing upon its patent. In the aftermath of the court ruling, Corcept's shares took a nosedive, plummeting nearly 38% after trading hours... Full

Federal Judge Declines to Block Colorado's EpiPen Affordability Law, For Now

(12/30, Michael Karlik, Colorado Politics) ...While U.S. District Court Judge Daniel D. Domenico turned down the request for a preliminary injunction, he also rejected Colorado's motion to dismiss the case outright. EpiPen manufacturer Teva Pharmaceuticals USA, Inc. had shown the state will likely violate its constitutional rights by taking its property without adequate compensation. "Here, there's no question what Teva has to give up should a pharmacy seek reimbursement — (EpiPens) or money," Domenico wrote in a Dec. 27 order. "Nor is there uncertainty about how the affordability program works — if Teva refuses to reimburse a pharmacy with its personal property or money, it faces a monetary sanction."... Full

The Heroes of Teva

(12/24, Alan Rosenbaum, The Jerusalem Post) ...Companies are far more than numbers on a balance sheet, a stock price, or the subject of a long-range business forecast. They are people. Since the war started, it is due to the people of Teva that the company continued to steadily supply medicine and medical equipment to meet the demand that has tripled while also expanding its donations and volunteering activities... Full

Reliever Inhalers Used More On Days With High Wildfire-Related Air Pollution

(12/26, Isabella Hornick, Healio) ...In a retrospective analysis, Burnette and colleagues evaluated 14 patients with asthma who lived in a region affected by the Canadian wildfires between May 28 and June 17, 2023, to assess patterns of short-acting beta agonist inhaler usage through the Digihaler (Teva Pharmaceuticals) electronic inhaler that collects user data. These data are available to patients through an app and to clinicians through a web-based dashboard. Within the timeframe, patients had to use the Digihaler a minimum of one time, [Autumn F. Burnette, MD, FACAAI, assistant professor in the division of allergy and immunology at Howard University Hospital] said... Full

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

(1/1, Dean Rudge, Generics Bulletin) ...Alvotech is set to face a long-awaited US Food and Drug Administration reinspection of its Reykjavik facility in January, in a key milestone for the Icelandic firm that could pave the way finally to a US approval for its Teva-partnered AVT02 adalimumab high-concentration interchangeable biosimilar to Humira. The FDA's reinspection at Reykjavik has been scheduled for 10-January 19... Global Sub. Full

Exclusive: Drugmakers Set to Raise US Prices On At Least 500 Drugs in January

(12/29, Michael Erman and Patrick Wingrove, Reuters) ...Drugmakers including Pfizer, Sanofi and Takeda Pharmaceutical plan to raise prices in the United States on more than 500 drugs in early January, according to data analyzed by healthcare research firm 3 Axis Advisors. Excluding different doses and formulations, more than 140 brands of drugs will have their prices raised next month, the data showed... Full

Problems Are Expected After An Asthma Inhaler Is Replaced With Generic Version

(12/29, A Martínez, Sydney Lupkin, NPR) ...A popular asthma inhaler is being discontinue. The drug called Flovent will no longer be available starting in January. And some patients might not be able to switch drugs right away, leaving a gap in their medical care and putting them at risk for complications. NPR pharmaceuticals correspondent Sydney Lupkin is here to tell us more about this... Full

‘A Huge Shock to the System': Doctors Warn About Asthma Inhaler Switch Coming in January

(12/28, Meg Tirrell, CNN) ..."This medication has been the most commonly used inhaled medication for the past 25 or 30 years," said Dr. Robyn Cohen, a pediatric pulmonologist at Boston Medical Center. "It's the one that, overwhelmingly, pediatricians reach for when they decide that their patient needs a daily preventive medication. … The fact that it's being discontinued is going to be a huge shock to the system for patients, for families and for doctors."...A spokeswoman for GSK said the company is making the change "as part of our commitment to be ambitious for patients."... Full

How Lowering The Price of a Common Asthma Drug Made It Harder to Get

(12/29, Joseph Walker, The Wall Street Journal) ...The fallout from Flovent HFA being pulled off the market is another indication of how hard it can be to lower drug prices and the unintended consequences of government policies designed to promote lower costs...Glaxo earlier this year decided to pull the brand-name drug off the market entirely on Jan. 1. The company hoped patients would switch to an unbranded version of the same product introduced by its partner Prasco in March... Sub. Req'd

A Popular Asthma Inhaler is Leaving Pharmacy Shelves. Here's What You Need to Know

(12/30, Sydney Lupkin, NPR) ...GSK says it's discontinuing Flovent because it's making a generic version instead. "These authorized generics will provide patients in the US with potentially lower cost alternatives of these medically important products," a GSK spokesperson wrote in a statement to NPR. "We recognize that patients have a number of options in the therapeutic area and therefore remain committed to ensuring the affordability of our medicines."... Full

Regeneron Fends Off Viatris' Eylea Biosimilar With Patent Win

(12/29, Zoey Becker, Fierce Pharma) ...A West Virginia judge ruled that Viatris' proposed biosimilar violates a Regeneron patent that covers ophthalmic formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist suitable for intravitreal administration to the eye. That patent is expected to expire in June 2027... Full

Formycon Announces EMA Acceptance of the MAA for FYB203, A Biosimilar Candidate to Eylea® (Aflibercept)

(12/27, Formycon AG) ...Formycon AG and its license partner Klinge Biopharma GmbH announce that the European Medicines Agency has accepted the marketing authorization application for FYB203, a biosimilar candidate to Eylea®1 (Active Ingredient: Aflibercept), for review... Full

Lawsuit Claims J&J Illegally Delayed Stelara Biosimilars

(1/1, Phil Taylor, PharmaPhorum) ...According to court documents, other allegations include that J&J and its Janssen Biotech unit misrepresented facts to the patent examiner, and acquired a biosimilar drugmaker – Momenta Pharma – in 2020 to block the entry of competitors. The Momenta deal gave it rights to a manufacturing patent and other intellectual property that allowed it to delay competition from Amgen, Samsung Bioepis, Alvotech/Teva, and Celltrion, says the complaint. The lawsuit has emerged after the first Stelara biosimilar – Amgen's Wezlana – was approved on 31st October as an interchangeable option for all of Stelara's approved indications but will be able to reach the US market "no later than" 1st January 2025 after a settlement with J&J... Full

Celltrion Starts Anew After its Merger with Celltrion Healthcare

(12/28, Lee Han-soo , Korea Biomedical Review) ...The Celltrion Group announced the launch of the integrated entity of Celltrion and Celltrion Healthcare, in which Celltrion will be absorbing Celltrion Healthcare to form a single entity, on Thursday. The scheduled date for the listing of new shares resulting from this merger is Jan. 12, 2024, and securities analysts predict that the post-merger market capitalization is predicted to be around 40 trillion won ($31 billion), which would place it within the top 10 in terms of market capitalization in the KOSPI market... Full

Celltrion to Sell Portfolio of Takeda Drugs to CBC Group

(12/31, Dae-Kyu Ahn, The Korea Economic Daily) ...South Korea's Celltrion Inc. will divest a portfolio of Takeda Pharmaceutical's prescription medicines sold in Asia to CBC Group, a Singapore-based investment firm, according to sources familiar with the matter on Monday. It is also in the final stages of talks to sell the exclusive domestic sales rights for some over-the-counter drugs of the Japanese company to a large Korean pharmaceutical firm, the sources said... Full

Celltrion Confirms Interchangeability of Yuflyma and Humira in Phase 3 Psoriasis Trial

(12/26, Kim Jung-chul, Korea Biomedical Review) ...Celltrion said Tuesday it confirmed interchangeability between Yuflyma (adalimumab), an autoimmune disease biosimilar, and the original drug AbbVie's Humira, in a global phase 3 psoriasis clinical trial. Based on the clinical results, Celltrion plans to get approval from the U.S. FDA for the interchangeability between Yuflyma and Humira... Full

Aurobindo Pharma Arm Receives USFDA Approval for Posaconazole Injection, Shares Up

(12/27, Arushi Mishra, The Hindu) ...Aurobindo Pharma Ltd's wholly-owned subsidiary, Eugia Pharma Specialities Ltd, has obtained final approval from the US Food & Drug Administration to manufacture and market Posaconazole Injection, 300 mg/16.7 mL (18 mg/mL), Single-Dose Vial. The product is bioequivalent to the reference listed drug Noxafil Injection, by Merck Sharp & Dohme LLC... Full

FDA Approves On-Body Injector Presentation of Pegfilgrastim Biosimilar Udenyca

(12/27, Brian Park, PharmD, MPR) ...The Food and Drug Administration has approved an on-body injector presentation of Udenyca® (pegfilgrastim-cbqv), a biosimilar to Neulasta...Udenyca Onbody is expected to be available in the first quarter of 2024 and will be supplied in a carton containing 1 on-body injector co-packaged with 1 prefilled syringe... Full

Emcure Expands Injectables Capacity, Opens 3rd Facility in Gujarat

(1/2, Financial Express) ...The third injectable facility of Emcure Pharmaceuticals in Mehsana, Gujarat, which was commissioned in August 2023, is now ready for commercial supplies to domestic and international markets. The company already has an oral formulations manufacturing line in Mehsana..."The new Mehsana facility will help us meet the growing demand for our differentiated product portfolio across markets," said Satish Mehta, founder and CEO, Emcure Pharmaceuticals... Full

Torrent Pharma Gets 5 Observations from USFDA for Gujarat Unit

(1/2, CNBC TV 18) ...CNBC-TV18 has accessed Form 483 issued to Torrent Pharmaceuticals's Chhatral unit in Gujarat. The US health regulator has issued five observations to the pharmaceutical company after inspecting its site from December 5 to December 11... Full

Aurobindo Pharma Arm's New Injectable Facility in New Jersey Gets 10 Observations from U.S. FDA

(12/25, The Hindu) ...A new injectable facility of Aurobindo Pharma's step-down subsidiary Eugia US Manufacturing LLC in New Jersey, U.S., has been issued 10 observations by the United States Food and Drug Administration after a pre-approval inspection. "The inspection closed with 10 observations. The observations are procedural in nature and will be responded to within the stipulated time. The plant is yet to start commercial operations," the drugmaker said in a filing on Sunday... Full

Pfizer's Hospira Recall Spree Bleeds into 2024 with Product Pulls for Multiple Hospital Drugs in Shortage

(12/27, Fraiser Kansteiner, Fierce Pharma) ...Shortly before the holiday, Pfizer's Hospira announced two separate recalls over the potential presence of glass particulates in vials and syringes of certain meds. In the case of injectable cancer medication bleomycin—of which Hospira is recalling one lot—a confirmed customer report alerted the company to the presence of glass particulates within a single vial, the company said in a notice posted on the FDA's website... Full

Respiratory Virus Activity is High and Rising Across the United States, CDC Data Shows

(1/1, Carma Hassan, Deidre McPhillips, Amanda Musa and Carma Hassan, CNN) ...As seasonal virus activity surges across the United States, experts stress the importance of preventive measures – such as masking and vaccination – and the value of treatment for those who do get sick. Tens of thousands of people have been admitted to hospitals for respiratory illness each week this season. During the week ending December 23, there were more than 29,000 patients admitted with Covid-19, about 15,000 admitted with the flu and thousands more with respiratory syncytial virus, or RSV, according to data from the US Centers for Disease Control and Prevention... Full

McKinsey to Pay $78 Million in US Opioid Settlement with Health Plans

(12/29, Nate Raymond, Reuters) ...Consulting firm McKinsey & Co has agreed to pay $78 million to resolve claims by U.S. health insurers and benefit plans that it fueled an epidemic of opioid addiction through its work for drug companies including OxyContin maker Purdue Pharma... Full

Editorial: Double Dipping in Opioid Lawsuits

(1/1, The Wall Street Journal) ...The plaintiffs bar never met a business it wouldn't sue, and now the lawyers are using government authority to pursue private interests. In their latest business model, trial lawyers are hired by state attorneys general to help prosecute public lawsuits then use it to the advantage of their private lawsuits... Sub. Req'd

More Than Just Humira: US Biosimilars Enjoy An Eventful 2023

(12/31, David Wallace, Generics Bulletin) ...The launch of competition to Humira was the main event for US biosimilars this year – but a number of other key developments also took place in 2023, including settlements on Stelara that set up a series of launches in 2025, as well as first approvals for ustekinumab, natalizumab and tocilizumab biosimilars. In 2023, one story dominated the headlines for the US biosimilars sector: the debut of biosimilar competition to AbbVie's top-selling Humira (adalimumab) immunology brand... Global Sub. Full

The Long Learning Curve For Artificially Intelligent Drug Manufacturing Begins Now

(12/29, Bowman Cox, Pink Sheet) ...The pharmaceutical sector has quickly begun using artificial intelligence and machine learning models (AI/ML) in manufacturing and quality assurance, participants in recent workshop discussions indicated – but is unlikely to give the technology control over manufacturing processes or product release anytime soon. Meanwhile, pharmaceutical manufacturers are working to optimize the AI/ML models they are using, for example by relying on recent regulatory innovations to capitalize on their learning abilities even in the context of good manufacturing practices requirements that inhibit change... Sub. Req'd

Abortion, Drug Pricing Top Biden List of 2024 Health Challenges

(1/2, Ian Lopez, Bloomberg Law) ...The agency is heading into 2024 with a handful of proposed rules awaiting finalization, as well as guidance for implementing a landmark program allowing the government to negotiate what Medicare pays for high-cost drugs that is under attack from the pharmaceutical industry. "This promises to be a momentous year for public health, and it could get ugly for the White House and HHS," said Lawrence Gostin, faculty director of Georgetown University's O'Neill Institute for National and Global Health Law... Sub. Req'd

Big Pharma Is Raising Prices This Month

(1/1, Suzanne Blake, Newsweek) ...Inflation in 2024 isn't specific to big pharma. Nearly all industries, from restaurants to retail, are hiking prices for consumers as overall inflation stood at 3.1 percent across all goods and services. "There's been a significant rise in labor costs due to a more competitive job market and increased minimum wages in many areas," Aaron Anderson, the CEO and founder of franchise consulting firm Axxeum Partners, told Newsweek... Full

GSK to Cut US Prices for Advair, Valtrex and Lamictal

(12/22, Michael Erman, Reuters) ...Drugmaker GSK Plc said on Friday that it will cut U.S. list prices on asthma drug Advair, herpes drug Valtrex, and anti-epileptic medication Lamictal on Jan. 1, 2024...According to a GSK spokesman, the company plans to cut list prices by up to 70% on Advair, up to 48% on Lamictal and 10% for Valtrex. List prices do not include rebates to pharmacy benefit managers and other discounts... Full

More Americans Can Now Get Insulin for $35

(1/1, CBS News) ...Sanofi is joining the nation's two other major insulin manufacturers in offering either price caps or savings programs that lower the cost of the drugs to $35 for many patients. The three drugmakers are also drastically lowering the list prices for their products. The moves were announced in the spring, but some didn't take effect until January 1... Full

Insurance Coverage Makes Common Generic Drugs More Expensive

(1/1, Ge Bai, Forbes) ...For low-cost common generic drugs, insurance coverage inevitably creates wasteful spending for patients, workers, employers and taxpayers. As insurance coverage result in many patients facing high out-of-pocket payments for common generic drugs, cash-pay business models—such as Amazon Pharmacy, Costco, GoodRx, and Mark Cuban Cost Plus Company—have entered the arena to satisfy patients' unmet demand for lower out-of-pocket payments. Their competition exerts downward pressure on generic drug prices... Full

Major Changes In Drug R&D Trends Unlikely To Be Tied To Negotiation, Analysis Finds

(12/28, Gabrielle Wanneh, InsideHealthPolicy) ...While the drug industry and GOP lawmakers say the Inflation Reduction Act's Medicare drug price negotiation program disincentivizes industry from developing new medicines, a recent policy brief by the health care research and advisory services firm ATI Advisory found most drug companies' innovation decisions in the first half of 2023 were more likely attributed to ongoing macroeconomic or company-specific trends rather than a direct result of the IRA... Sub. Req'd

IRA Likely to Lead to Higher Drug List Prices and Bigger Rebates, Congressional Budget Office Predicts

(12/27, Lia DeGroot, Endpoints News) ...In a letter sent to House Budget Committee Chair Jodey Arrington (R-TX) and Michael Burgess (R-TX) on Dec. 21, CBO Director Phillip Swagel responded to the lawmakers' request for more information on how the office is assessing the impact of the IRA. The CBO said it expects the list price of drugs entering the market to go up in response to the IRA's inflation-rebate provisions and, to a lesser extent, the Medicare drug price negotiation provisions... Full

The Inflation Reduction Act's Harms Go Beyond Drug Pricing — They're Threatening Your Medicare

(12/23, Joe Grogan, The Hill) ...The IRA threatens to deliver disaster across the entire innovation, financing and distribution system for prescription drugs. This intricate system is the consequence of decades of hard-fought negotiation and compromise encapsulated by the Orphan Drug Act, Hatch-Waxman, the Prescription Drug User Fee Amendments, the Medicare Modernization Act, and other bipartisan initiatives. The IRA's partisan nature, by contrast, jeopardizes the systems these laws built... Full

ICER: Price Hikes Of 8 Drugs Without Clinical Evidence Adds $1.5B To Health Care Spending

(12/26, Maaisha Osman, InsideHealthPolicy) ...AbbVie's blockbuster drug Humira topped a list of eight drugs with price hikes that elevated U.S. health care spending by $1.3 billion in 2022 despite lack of new evidence supporting their health benefits, according to the drug price watchdog Institute for Clinical and Economic Review's (ICER) latest yearly report...David Rind, chief medical officer at ICER, told IHP "manufacturers are always given the option to provide the correct net pricing, and many choose to do so if they feel that ICER's numbers are incorrect."... Sub. Req'd

Employer Plans Fear State Crackdown on Drug Purchase Middlemen

(12/26, Sara Hansard, Bloomberg Law) ...Groups representing companies with self-insured health plans say the states' attempts to fill the void on PBM legislation threaten preemption protections under the federal Employee Retirement Income Security Act. What's more, maintaining a nationally uniform regulatory system under ERISA, which turns 50 in 2024, is necessary to avoid a problematic patchwork of state laws, the employer groups say... Sub. Req'd

Washington Grappling With Fixes to America's Shortages of Vital Drugs

(12/26, Tom Howell Jr., The Washington Times) ...Rep. Earl L. Carter, a Georgia Republican who is a pharmacist, is pushing a bipartisan bill that would require the federal government to help stockpile 50 essential generic drugs. "The United States is dependent on China for our life-saving medications, which gives its communist regime influence over Americans' health and well-being. By stockpiling essential medicines, the same way we do oil and other vital resources, we will ensure that medicines are available to patients, regardless of supply chain crunches or international conflicts," Mr. Carter told The Washington Times... Full

How Rock-Bottom Prices Drive Shortages of Generic Drugs Used in Hospitals

(12/28, Sydney Lupkin, NPR) ..."For off-patent generic drugs, especially those used in the hospital setting, Americans actually pay lower prices than Europe does," said Rena Conti, a professor at the Boston University Questrom School of Business...Over time, prices can get so low that it doesn't always make good business sense for the companies to keep making some drugs. So they stop. "It's the same issues that we've been dealing with for many years, especially with these older generic drugs that are having fewer and fewer manufacturers making them," Valerie Jensen, associate director for drug shortages at the Food and Drug Administration, told NPR... Full

What Will It Take for the US to Solve Drug Shortages?

(12/27, Riley Griffin, Bloomberg) ...Drug shortages soared to near-record highs, leaving patients suffering from cancer, bacterial infections and other ailments without treatment. The culprit behind the scarcity has more often than not been a quality issue — the type that forces manufacturers to slam the brakes on production...[Biden's domestic policy adviser Neera] Tanden says one of the factors that make drug shortages more likely is that manufacturers are more focused on profits than quality. So they may be loath to make investments in the production process that improve the medicines, but could hurt the bottom line. The White House is exploring how to use the purchasing power of the US government to address this, she says... Sub. Req'd

White House Wants Naloxone in Federal Buildings

(12/22, Nathaniel Weixel and Joseph Choi, The Hill) ...The first update to federal building safety guidelines since 2009 is aimed at making the opioid reversal drug more accessible. The Department of Health and Human Services (HHS) and the General Services Administration, which oversees federal real estate, are calling for all federal buildings to include the opioid overdose reversal drug naloxone onsite, alongside automated external defibrillators (AEDs)... Full

GSK, Amneal, Kaléo Delist Patents from FDA's Orange Book

(12/22, Mariela Rosales and Brad Smith, Yahoo! Finance) ...Pharmaceutical companies, GSK, Amneal Pharmaceuticals and Kaléo have agreed to delist some of their patents from the FDA's orange book. GSK withdrew four inhaler patents and Amneal withdrew epinephrine injection patents. This comes after the Federal Trade Commission sent notices to several pharma companies for wrongfully-listed patents, which included AbbVie, AstraZeneca, Boehringer Ingelheim, Impax, Kaléo, Mylan, GSK, and Teva. Yahoo Finance Healthcare Reporter Anjalee Khemlani discusses what this means for the pharmaceutical industry... Full

E&C GOP Threatens FDA Subpoena Over Foreign Inspection Issues

(12/27, Jessica Karins, InsideHealthPolicy) ...Republicans on the House Energy & Commerce Committee say they will issue a subpoena if FDA doesn't respond by Jan. 5 to their requests for information about the agency's foreign inspections regime, as they seek more insight into how FDA has handled quality issues with products from India and China and take officials to task for not responding to previous letters... Sub. Req'd

Study: FDA Foreign Inspections Still Low After Pandemic, Alert Patients

(12/29, Jessica Karins, InsideHealthPolicy) ...The number of foreign pharmaceutical facilities inspected by FDA has never risen back to the level before the COVID-19 pandemic shut down most in-person inspections, researchers found, while at the same time citations for the few facilities inspected have significantly risen -- and the researchers suggest FDA increase its inspection workforce, step up foreign inspections and alert patients to potential drug quality issues... Sub. Req'd

Medicines For Europe's Leader Marks A Decade Of Change

(12/24, David Wallace, Generics Bulletin) ...Marking ten years as head of European off-patent industry association Medicines for Europe, Adrian van den Hoven talks about his experiences in the first part of a three-part interview with Generics Bulletin...In an exclusive in-depth three-part interview with Generics Bulletin, he discusses the changes seen in the European off-patent industry over the last ten years, the way Medicines for Europe has evolved as an organization, and the opportunities on the horizon for generics, biosimilars and off-patent medicines... Global Sub. Full

EU Critical Medicines Requirements ‘Could Worsen Shortages'

(12/27, Francesca Bruce, Pink Sheet) ...The publication of the EU's first critical medicines list is a welcome development as it could inform discussions between industry and EU bodies about far reaching changes to the EU's pharmaceutical legislation, according to Bengt Mattson, head of medicines supply at Lif, the Swedish pharmaceutical industry association...The list is good news because "now we at least know which medicines the European Union regards to be critical," Mattson told the Pink Sheet. He said this would be useful when it came to discussions on the EU pharmaceutical legislative reform... Sub. Req'd

EMA Homes In On Bacteriophages In Fight Against AMR

(12/29, Neena Brizmohun, Pink Sheet) ...The European Medicines Agency is looking to support the development and manufacture of bacteriophages for treating bacterial infections as part of its bid to tackle the dramatically increasing problem of antimicrobial resistance. While bacteriophages are a promising alternative to antibiotics for treating infections that do not respond to conventional treatment, the lack of regulatory and scientific guidance in this area appears to have discouraged bacteriophage drug development, the EMA explains in a concept paper that proposes to address this shortfall... Sub. Req'd

MHRA's New International Recognition Procedure (IRP) Goes Live

(1/2, The Pharma Letter) ...From January 1, 2024, developers of new medicines can now submit applications via the UK Medicines and Healthcare products Regulatory Agency's new, International Recognition procedure. The IRP will help bring life-saving medicines to UK patients and has been developed by the MHRA following the UK's departure from the European Union. It allows the Agency to take into account the expertise of trusted regulatory partners in other countries when authorizing medicines... Sub. Req'd

Ozempic and ADHD Medicine Shortages Could Worsen in 2024

(12/29, Alannah Francis, Inews) ...It is expected that shortages affecting ADHD medications will last well into 2024, while Ozempic supply issues may even last until 2025. Debra Ainge, CEO of iEthico, which connects pharmacists with medicines in short supply so they can deliver them to patients in need, told i: "There is a general problem with shortages that suppliers will be over-optimistic about when things will be back in stock and back available... Full

Celltrion Seeks Approval for Xolair Biosimilar in Canada

(12/27, Kim Jung-chul , Korea Biomedical Review) ...Celltrion said Wednesday that it has completed the submission of its marketing authorization application for its Xolair (omalizumab) biosimilar, CT-P39, to Health Canada... Full

Pharma Lobby Bats for Drug Approvals in India to Align With Global Markets

(12/29, Business Standard) ...To hasten the launch of new medicines in India, the Organisation of Pharmaceutical Producers of India, which represents key multinational pharmaceutical companies, has urged the drug controller to enable parallel approval of drugs in sync with global markets, reported The Economic Times...The lobby represents pharmaceutical titans such as Novartis, Roche, AstraZeneca, Sanofi, and Merck. The group attributes the delay to strict clinical trial regulations... Full

India's Pharma Ambitions Stumble as Imports Surge, PLI Scheme Under Scrutiny

(12/28, The Pharma Letter) ...The rise, despite flagship initiatives like Atmanirbhar Bharat Abhiyan and the Production Linked Incentive (PLI) scheme, has thrown a wrench in the government's ambitions and sparked questions about the effectiveness of its policies, reports The Pharma Letter's India correspondent. As an official with a domestic drug company said, the paradox exposes the intricate dance between government ambitions, economic realities, and global supply chains. It also turns the spotlight on swelling research costs and misaligned attempts to bridge the technological gap... Sub. Req'd

Trade Generics Growth to Dent Value Expansion of Domestic Drug Market

(12/25, Sohini Das, Business Standard) ...Rising penetration of trade generic medicines is eating into the value growth of the domestic pharmaceutical market, showed a recent analysis. According to a Kotak Institutional Equities analysis, 70-110 basis points (bps) annual dent is expected from trade generics and Jan Aushadhi on Indian Pharma Market (IPM) growth at least until FY27-28... Sub. Req'd

India Firm Denies Tampering With Tests in Probe of Cough Syrup Deaths

(12/23, Krishna N. Das, Reuters) ...India's Maiden Pharmaceuticals, whose cough syrups have been linked to the deaths of children in Gambia, on Saturday denied it had tampered with test samples or bribed officials to do so, as alleged in a complaint under investigation by local health officials..."I have never changed the sample," Maiden founder Naresh Kumar Goyal told Reuters. "There is no evidence and no proof against us. I have not given a bribe."... Full

THE ANDA BOOST

(12/27, Ramesh Shankar, Pharmabiz.com) ...The leadership position of the research-based Indian pharmaceutical companies continues in getting the Abbreviated New Drug Applications (ANDA) approvals from the US FDA. In spite of several headwinds, the Indian pharmaceutical companies have grabbed higher ANDA approvals from US FDA during the first nine months ended September 2023... Full

2024 Forecast: Big Pharma Reworks China Strategy, and Job Cuts are Part of It

(12/22, Angus Liu, Fierce Pharma) ...In the last few months of 2023, Pfizer, GSK, Sanofi and Biogen have each tapped local partners to help commercialize their products in China. With marketing responsibilities shifting to other firms, job cuts were expected at each of those large drugmakers. It's not a new approach for foreign drugmakers to tap local partners in China, Justin Wang, head of L.E.K. Consulting's China practice, pointed out in an email interview with Fierce Pharma. But these deals are on the rise lately, Wang explained, partly because "there is increasing pricing and competitive pressure in the market, especially for mature products, leaving reduced [return on investment] for in-house commercial resources."... Full

Germany's Stada Has Spun Off Russian Business - Newspaper

(12/22, Rachel More and Emma-Victoria Farr, Reuters) ...Generic drugmaker Stada has spun off its Russian business into a separate company called Nizhpharm, the Welt am Sonntag newspaper reported on Saturday, citing a spokesperson from the German company. Nizhpharm will operate independently and autonomously, the newspaper cited a spokesperson as saying... Full

Analysts Expect Tightening of Competition in Russian Pharma Market in 2024

(12/28, The Pharma Letter) ...The level of competition in the Russian pharmaceutical market will significantly tighten next year, as local drugmakers plan to overtake global producers in the segment of public procurements, reports The Pharma Letter's local correspondent. One of such companies is Biocad, which is trying to get its Ivlizi (divozilimab), a treatment for multiple sclerosis, to be included in the list of vital drugs. That will allow Biocad to participate in state tenders with this drug... Sub. Req'd

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