Friday, February 14, 2025

Please note: Teva Daily News will observe the U.S. Presidents’ day holiday and resume publication on Tuesday, February 18.

India's GlaxoSmithKline Pharma Reports Higher Profit On Strong Demand for Respiratory Drugs

(2/14, Kashish Tandon, Reuters) ...India's GlaxoSmithKline Pharmaceuticals reported a higher adjusted third-quarter profit on Friday, led by sustained demand for its respiratory drugs and antibiotic Augmentin...GlaxoSmithKline Pharma has been benefitting from rising market share for its antibiotic Augmentin and respiratory drugs Nucala and Trelegy. Strong demand for its vaccine for shingles, Shingrix, has also boosted earnings, the company said... Full

Zydus' Third Quarter Results Met With Mixed Analyst Reactions

(2/13, Adam Zamecnik, Generics Bulletin) ...Zydus Lifesciences reported a mixed third fiscal quarter, with misses in its domestic Indian business that were offset by growth in the US market where the firm also has multiple opportunities lined up for the near future. Overall, the firm's revenue grew by 17% year-over-year to INR 52.7bn ($607.6m), marking a 1% quarter-to-quarter growth. The company reported INR13.9bn in EBITDA, with a margin of 26.3%. Altogether, the company reported a net profit of INR10.2bn in the third quarter, which marked a 30% year-over-year increase... Global Sub. Full

Zydus and Synthon Ink Exclusive Development, Licensing & Commercialization Agreement for a Novel 505(B)(2) Oncology Product for US Market

(2/14, Pharmabiz.com) ...Zydus Lifesciences Ltd. (including its subsidiaries and affiliates), a global innovation driven healthcare company announced that it has signed an exclusive development, licensing, supply and commercialization agreement with Synthon BV, a vertically integrated, global leader in the development and manufacturing of complex generic drugs, of the Netherlands for a novel 505(B)(2) oncology product for an undisclosed target... Full

Glenmark Pharma's US Arm Launches Latanoprost's Bioequivalent Solution

(2/14, Business Standard) ...Glenmark Pharmaceuticals said that US-based Glenmark Pharmaceuticals Inc. has launched Latanoprost Ophthalmic Solution. The aforementioned solution is bioequivalent and therapeutically equivalent to the reference listed drug Xalatan Ophthalmic Solution of Upjohn US 2 LLC... Full

Janssen Korea's Concerta Supply Strained Amid Soaring ADHD Prescriptions and Tighter Controls

(2/14, Kim Ji-hye, Korea Biomedical Review) ...A shortage of Concerta (methylphenidate), a medication widely used to treat attention deficit hyperactivity disorder (ADHD), has raised concerns in Korea, as patients and doctors navigate limited supply and regulatory changes that could further impact access. Janssen Korea, the importer of Concerta, confirmed the supply issue on Tuesday, attributing it to global production constraints, increasing demand, and regulatory delays in multiple countries... Full

U.S. Investors, Big Pharma Race to Find New Medicines in China

(2/13, Angelica Peebles, CNBC) ...U.S. investors like Bain Capital Life Sciences and large pharmaceutical companies like Merck are increasingly looking for new medicines in China. Almost 30% of Big Pharma deals with at least $50 million up front came from China last year, up from 20% the year before and 0% only five years before, according to data from DealForma. The increase in China deals comes as President Donald Trump and U.S. policymakers pursue protectionist policies in technology like artificial intelligence and semiconductors... Full

Aurobindo Says US Tariffs ‘Not A Challenge' For Now

(2/13, Vibha Ravi, Pink Sheet) ...Swami Iyer, the CEO for generic drug supplier Aurobindo's US arm, Aurobindo Pharma USA Inc., downplayed tariff concerns, saying "It's a lot of noise right now." "We don't know what's the final outcome," he said during a February 7, company call. "We do know that from China, there is some input tariff. But there's nothing that we believe is going to be a challenge for us."... Global Sub. Full

Trump's Reciprocal Tariffs Would Hit These European Union Products That Americans Buy The Hardest

(2/13, Lori Ann LaRocco, CNBC) ...The top U.S. import from the EU in 2024, by category and dollar value, was pharmaceutical products, according to data from the U.S. Trade Census analyzed by ImportGenius. Included in that $127 billion worth of EU imports was semaglutide, an ingredient used in the popular GLP-1 weight loss drugs from Novo Nordisk and Eli Lilly, such as Ozempic, Wegovy, and Mounjaro. The GLP-1 compound was the sixth-largest import from the EU to the U.S., at $15.6 billion. The drug and medical industry, overall, will experience among the most significant tariff impacts by sector... Full

EU Calls Trump's Reciprocal Tariffs Plan Step in Wrong Direction

(2/14, Kevin Whitelaw, Bloomberg ) ..."The EU will react firmly and immediately against unjustified barriers to free and fair trade, including when tariffs are used to challenge legal and non-discriminatory policies," [European Commission President Ursula von der Leyen] said Friday in a statement. She added, "Tariffs are taxes. By imposing tariffs, the US is taxing its own citizens, raising costs for business, stifling growth and fueling inflation."... Sub. Req’d

Trump Moves to Impose Reciprocal Tariffs As Soon As April

(2/13, Josh Wingrove, Jennifer A. Dlouhy and Jenny Leonard, Bloomberg) ...The president on Thursday signed a measure directing the US Trade Representative and Commerce secretary to propose new levies on a country-by-country basis in an effort to rebalance trade relations — a sweeping process that could take weeks or months to complete. Howard Lutnick, Trump's nominee to lead the Commerce Department, told reporters all studies should be complete by April 1 and that Trump could act immediately afterward...Trump told reporters that he would enact import taxes on cars, semiconductors and pharmaceuticals "over and above" the reciprocal tariffs at a later date... Sub. Req’d

RFK Jr. Confirmed As HHS Secretary

(2/13, Ferdous Al-Faruque, Regulatory Focus) ...After the Senate confirmed Kennedy to lead HHS, the pharmaceutical lobby group PhRMA said it looked forward to working with Kennedy. "During his confirmation hearings, Secretary Kennedy discussed the need to reduce the burden of chronic disease, improve health outcomes and make health care more affordable for the American people," said PhRMA CEO Stephen Ubl. "A key part of the solution is to strengthen the ecosystem that makes our country the best place in the world to develop new medicines."... Full

RFK Jr. Confirmed As HHS Secretary: Here's How Pharma Might Be Impacted

(2/13, Lecia Bushak, MM+M) ...At face value, Kennedy has appeared to align more closely with progressives on drug pricing issues than industry-friendly conservatives. He has repeated the argument common among drug pricing reform advocates that Americans shouldn't be paying more than other countries for the same drugs. Additionally, he has singled out Big Pharma companies as being too closely intertwined with the federal agencies that regulate them... Full

Cantwell Reintroduces Bipartisan Bill to Hold PBMs Accountable for Driving Up Drug Costs

(2/13, United States Senator for Washington Maria Cantwell) ...Today, U.S. Senator Maria Cantwell (D-WA), ranking member of the Senate Committee on Commerce, Science, and Transportation and senior member of the Senate Finance Committee, joined U.S. Senator Chuck Grassley (R-IA) in reintroducing the Pharmacy Benefit Manager Transparency Act, which would increase drug price transparency and hold Pharmacy Benefit Managers accountable for unfair and deceptive practices that drive up prescription drug prices. This legislation will reduce prescription costs for consumers and save taxpayers $740 million... Full

PBMs vs. The World: ‘Invisible Middlemen' of Healthcare Industry Face Continued Scrutiny

(2/13, Heerea Rikhraj, MM+M) ...Joshua Fredell, VP and head of PBM and special product innovation at CVS Health, claims there is always going to be a "push-pull tension" between PBMs and drugmakers, but added this is natural when two industries work together closely. Despite this assertion, the relationship between PBMs and pharma is best represented by a public blame game... Full

The Power of PBMs and Biosimilars, 2025 Launches of the Stelara Biosimilars, the IRA and Interchangeability | Q&A with Craig Burton, MBA

(2/12, Peter Wehrwein, Managed Healthcare Executive) ...The second part of our conversation with Craig Burton, MBA, executive director of the Biosimilars Council, a trade and lobbying group for the biosimilars industry... Full

Reminder: Rebates Have No Correlation With High Drug Prices

(2/13, PCMA) ...Conclusions across various reports have found that rebates secured by PBMs are NOT correlated to high and increasing list prices set solely by drug companies. Instead of interfering in the private market with misguided government mandates that benefit Big Pharma, Congress should reject those policies and focus on holding drug companies accountable for their egregious pricing practices... Full

Trump Expands Bid To Slash Agencies, Biologics Firms Warn Cuts Would Devastate FDA

(2/13, Jessica Karins, Inside Health Policy) ...A group of stakeholders led by small biopharma companies recently signed onto an open letter to the Trump administration urging it to spare FDA from proposed budget and personnel cuts, warning that a reduction in the agency's workforce would endanger innovation and that the specialized scientists and staffers at FDA are "not easily replaced."... Sub. Req’d

Could PDUFA VIII Align With Trump's Efficiency Emphasis?

(2/13, Sue Sutter, Pink Sheet) ......"I think this is an opportunity for us to sit back and say what is working and what is not working," Remy Brim, principal and healthcare practice head at BGR Government Affairs, said February 11 at the Biotechnology Innovation Organization's CEO and Investor Conference. "We have an opportunity as industry to rethink what we're doing here, and the rethink is going to help us preserve that really delicate balance and that need for that industry funding."... Global Sub. Full

GDUFA And Facility Readiness: A New Era for Generic Drug Approvals

(2/13, Ravali Patlolla and Freyr Solutions, Pharmaceutical Online) ...Since its inception in 2012, GDUFA has undergone two reauthorizations, with the most recent being GDUFA III for fiscal years 2023–2027. This latest revision introduces significant changes to the generic drug approval process, with particular emphasis on improving facility readiness and refining goal date assignments. These updates are designed to streamline the approval process further and enhance the availability of affordable generic medications... Full

Legislation Seeks to Lower Prescription Costs

(2/13, WSJM) ...Lawmakers in Michigan have introduced a package of bills designed to lower costs and expand healthcare access. Senate Bill 3 would create a Prescription Drug Affordability Board, made up of experts in economics, healthcare, supply chain management and academia, with no ties to the pharmaceutical industry. Their aim would be to cut costs and protect people's health and finances, by keeping prescription drug prices fair and transparent... Full

California Judge Knocks Down State Law Barring ‘Pay-for-Delay' Drug Industry Deals

(2/13, Alan Riquelmy, Courthouse News Service) ...A lengthy court battle over a California law regulating prescription drug settlements ended Thursday when a federal judge ruled the state couldn't enforce the rule outside its borders... Full

Indiana Bills Unfairly Target Pharmacy Benefit Managers | Opinion

(2/14, Jim Merritt, IndyStar) ...Legislation like Indiana Senate Bill 140 and House Bill 1606 introduced last month, along with misguided proposals being considered in Congress, unfairly target pharmacy benefit managers (PBMs) under the guise of reform. These efforts would strip employers of the tools they rely on to offer quality prescription drug coverage at an affordable price, ultimately raising costs for businesses and workers... Full

The India-US TRUST Initiative: What is it, and How Will it Strengthen the Critical Minerals and Pharma Supply Chains

(2/14, Aggam Walia, Indian Express) ...The TRUST initiative's effort to create robust supply chains for pharma could focus on active pharmaceutical ingredients (APIs), many of which depend on critical minerals like lithium, magnesium, zinc, and selenium. India is the world's second largest manufacturer of APIs after China. Pharma products made up the largest share (21.9%) of the $20 billion worth of final consumer goods that India exported to the US in 2023. The pharma sector is vulnerable to tariffs that the Trump administration may decide to impose... Full

India's Bio-Economy to Unleash its Potential with Robust Bio-Manufacturing Infra, Microbial Bio-Repository: Experts

(2/14, Nandita Vijayasimha, Pharmabiz.com) ...The strategic integration of bio-manufacturing capabilities with a well-curated microbial bio-repository can position India as a global leader in the bio-economy. Enhanced funding, regulatory support, and technology-driven interventions will be key to realizing this vision, stated experts... Full

Biosimilars: Expanding Access to Essential Biologic Therapies

(2/13, World Health Organization) ...Despite the demonstrated benefits, several challenges remain in the broader adoption of biosimilars. Regulatory barriers, lack of awareness among healthcare professionals, and limited manufacturing capabilities in certain regions can hinder the widespread acceptance and utilization of biosimilars. Addressing these challenges requires coordinated efforts among governments, healthcare providers, and the pharmaceutical industry to promote education, streamline regulatory processes, and invest in local manufacturing infrastructure... Full

Metz: The EU Must Be ‘Strict' and Set ‘Clear Conditions' with the Pharmaceutical Industry

(2/13, Thomas Mangin, Euractiv) ...With a legislative act on critical medicines and a pharmaceutical package in the making, the European Parliament is heavily engaged in health-related issues. Not to mention the return of Donald Trump to power in the United States, which brings its share of uncertainties and concerns. Euractiv spoke with MEP Tilly Metz, vice-chair of the Parliament's newly established Health Committee... Full

Dutch Struggling to Provide Patients with Quick, Affordable Access to Innovative Medicines

(2/13, Christoph Schwaiger, Euractiv) ...Quick and affordable patient access to innovative medicines remains an issue in many countries including the Netherlands, reports a new study. Rising healthcare spending is often attributed to an ageing population coupled with the high costs of innovative medication. In the Netherlands, where life expectancy has risen to 80.6 years, the healthcare system needs to be prepared to deal with an increase in the incidence of diseases associated with older age... Full

Brazil Consults On How To Price Advanced Therapies

(2/13, Francesca Bruce, Pink Sheet) ...Brazilian authorities are seeking views on how advanced therapies should be priced as a first step towards developing new pricing regulations for these products. Brazilian pricing regulations currently have no provisions for advanced therapies. The medicines regulator, ANVISA, has published post-authorization monitoring reports on several advanced therapies... Global Sub. Full

BBC Continues to Erode Own Credibility by Vilifying China's Drug Policies

(2/14, Virginia Lee, China Daily) ...The recent BBC report on China's pharmaceutical industry is yet another example of the Western media's relentless and biased attacks aimed at discrediting China's progress. The article, cloaked in feigned concern for public health, manipulates anecdotal complaints, selectively presents unverified claims, and deliberately ignores the extensive safeguards in China's drug procurement system... Full

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