Wednesday, November 5, 2025

Teva Pharm Third-Quarter Profit Tops Estimates as Branded Drugs Gain

(11/5, Steven Scheer, Reuters) ...Teva Pharmaceutical Industries reported on Wednesday a higher-than-expected rise in third-quarter profit, helped by strong sales of its trio branded drugs to treat migraines, Huntington's disease and schizophrenia... Full

Teva Surges After Push Into Branded Drugs Drives Sales Beat

(11/5, Jessica Nix, Bloomberg) ...The Tel Aviv, Israel-based company has pushed into branded medications that have been drivers of the company's growth in recent years. Still, the generics business makes up the majority of Teva's revenue. "Our differentiated innovative portfolio is now a defining strength for Teva," Chief Executive Officer Richard Francis said in the earnings statement...Teva and the Centers for Medicare and Medicaid Services have negotiated a new price for the drug under the Inflation Reduction Act. The US government will announce the new price later this month and come into effect in 2027... Sub. Req’d

Teva Shares Soar on Strong Third-Quarter Performance

(11/5, Sophie Shulman, CTech) ...Teva reported strong third-quarter results, surpassing revenue expectations and raising its forecast for Austedo. The pharmaceutical company posted revenue of $4.5 billion, exceeding expectations of $4.3 billion and marking a 3% increase compared to the same period last year. Teva shares surged by over 10% following the news...On less positive news, Teva reported that exclusive talks with a potential buyer for its TAPI active ingredients division have ended without results. The company plans to resume its search for a buyer, a process that has been ongoing for more than a year, after CEO Richard Francis decided to pursue the sale of the division... Full

Teva Gains After Q3 Beat and Guidance Hike

(11/5, Dulan Lokuwithana, Seeking Alpha) ...Teva attributed revenue growth to higher revenue from its generic products and its movement disorder therapy, Austedo, in its U.S. segment..."Our innovative portfolio driving the 11th consecutive quarter of growth in the third quarter reflects the accelerating momentum of our transformation and the strength of our innovation-led Pivot to Growth strategy," CEO Richard Francis said... Full

Teva Pharma Boosts FY25 Adj. EPS Outlook As Q4 Results Top Estimates; Shares Up 9%

(11/5, RTT News) ...While reporting financial results for the third quarter on Wednesday, Teva Pharmaceutical Industries Ltd raised its adjusted earnings guidance for the full-year 2025, while trimming annual revenue outlook. For fiscal 2025, the company now projects adjusted earnings in a range of $2.55 to $2.65 per share on revenues between $16.8 billion and $17.0 billion. Previously, the company expected adjusted earnings in the range of $2.50 to $2.65 per share on revenues between $16.8 billion and $17.2 billion... Full

Teva Reports Q3 EPS 78c, Consensus 67c

(11/5, The Fly) ...Reports Q3 revenue $4.5B, consensus $4.33B. Richard Francis, Teva's President and CEO, said, "Our innovative portfolio driving the 11th consecutive quarter of growth in the third quarter reflects the accelerating momentum of our transformation and the strength of our innovation-led Pivot to Growth strategy. Our key growth drivers-particularly our innovative medicines-delivered a 33% increase in local currency, underscoring their impact on both patient outcomes and our financial performance..."... Full

More from AAM's GRx+Biosims October Meeting

(11/4, Bob Pollock, Lachman Consultants) ...On day two of AAM's October meeting, a panel including Jim Polli, Ph.D., Professor at the University of Maryland, Anna Scwenderman, Ph.D., Professor at the University of Michigan College of Pharmacy, and Aaron Josephson, Senior Director at Teva Pharmaceuticals, discussed the International Generic and Biosimilar Medicines Association's (IGBA) project update on Single Global Development for Generic and Biosimilar Medicines. Given that efforts toward international harmonization are in high gear and the need for conserving resources at companies is becoming increasingly important, this could not have been a timelier update... Full

Novo Nordisk Strikes US Medicare Price Deal

(11/5, Maggie Fick, Bhanvi Satija, Reuters) ...Novo Nordisk said on Wednesday it had agreed a price under the U.S. Medicare scheme for semaglutide, the active ingredient in its key drugs Ozempic and Wegovy, in a deal that some analysts said sounded less onerous than feared...The price will take effect in 2027. The announcement came alongside Novo's third-quarter earnings and a cut to its 2025 financial guidance for the fourth time this year... Full

Pfizer CEO: Terms Of ‘Very Lengthy' TrumpRx Deal Confidential To Avoid Antitrust Issues

(11/4, Maaisha Osman, Inside Health Policy) ...Pfizer CEO Albert Bourla said Tuesday (Nov. 4) the company's drug pricing agreement with the Trump administration remains confidential under the terms of what he described as a "very lengthy deal," adding that the administration has directed companies to keep the details private to avoid antitrust issues...A pharmaceutical industry expert said the TrumpRx agreements are private contracts between the administration and individual companies rather than part of a legislative framework like Medicare drug price negotiations, which is why they are subject to fewer disclosure requirements... Sub. Req’d

AstraZeneca's CEO Is Willing to Compromise — When It's for Trump

(11/5, Ashleigh Furlong and Lisa Pham, Bloomberg) ...As AstraZeneca Plc met with the US administration multiple times ahead of an agreement on drug price cuts, there was one near-constant presence. "I attended almost every single meeting," the chief executive officer of the British drugmaker says. While Soriot spoke with President Donald Trump on a number of occasions, including at a state dinner at Windsor Castle, he also met with everyone from Commerce Secretary Howard Lutnick to Trade Representative Jamieson Greer. Perhaps most critical, according to the CEO, was getting buy-in from Mehmet Oz's team at the Centers for Medicare & Medicaid Services... Sub. Req’d

Drugmakers Still Oppose Medicare Talks Despite Reaching Deals

(11/4, Nyah Phengsitthy, Bloomberg Law) ...Astellas Pharma Inc., AbbVie Inc., Bristol Myers Squibb Co., and GSK Plc are among the pharmaceutical companies that have shared or signaled that they have finalized talks with the US government involving their drugs selected for the Medicare Drug Price Negotiation Program...The agreements come as the Centers for Medicare & Medicaid Services is expected to announce in the next few weeks the results of the program's second cycle, which targeted 15 drugs including Novo Nordisk A/S' obesity and diabetes treatments Ozempic and Wegovy, AstraZeneca Plc‘s cancer treatment Calquence, and Merck & Co.'s diabetes drug Janumet. The agency said in an email that it remains on track to meet its deadline to release the negotiated drug prices by Nov. 30... Sub. Req’d

White House Nears Deal to Lower Obesity Drug Prices for Medicare Coverage

(11/4, Dan Diamond and Rachel Roubein, The Washington Post) ...The White House is expected to announce a deal this week with Eli Lilly and Novo Nordisk that would lower the price of their popular obesity drugs to $149 per month in some cases, according to four people familiar with the agreement who spoke on the condition of anonymity to preview the deal. The drugs would also be covered for some Medicare beneficiaries, potentially expanding access to the medication for millions of Americans, the people said. Medicare can cover Novo Nordisk's Ozempic and Wegovy to treat diabetes and Eli Lilly's Zepbound for sleep apnea, but the coverage does not extend to weight loss... Full

Trump Negotiating Deal With Ozempic Maker to Sell Some Weight-Loss Drugs for $149

(11/4, Liz Essley Whyte and Peter Loftus, The Wall Street Journal) ...The discussions are still ongoing, but if agreements are finalized, President Trump is expected to announce them Thursday morning at the White House, alongside pharmaceutical executives, the people said...The agreement would allow Medicaid coverage for the popular but pricey drugs known as GLP-1s, including bestsellers Wegovy and Zepbound, to treat obesity. And it would require Medicare to cover the drugs for obese people who are also at high risk of other health problems, the people familiar with the matter said... Sub. Req’d

Trump Now Uses Medicare Coverage As Leverage In Expected GLP-1 MFN Deals

(11/4, Luke Zarzecki, Maaisha Osman, Inside Health Policy) ...George Hampton, president and CEO of Currax Pharmaceuticals, which owns a weight-loss drug, said the move would be great for patients and make branded FDA-approved GLP-1s affordable. "Going forward, it is critical that this program cover all classes of obesity medications. This should be an easy decision because even with the new price, GLP-1s still cost 50 to 100% or even more than the other classes of AOMs, like Contrave," Hampton said. Sean Tunis, former chief medical officer for CMS, told IHP in a statement other makers of weight-loss drugs could challenge the re-interpretation of the statutory exclusion in Medicare Part D... Sub. Req’d

GoodRx Wants in on TrumpRx as it Grows its Work with Pharmaceutical Manufacturers

(11/4, Lydia Ramsey Pflanzer, Endpoints News) ...Whatever happens with TrumpRx, GoodRx has been leaning into working with pharmaceutical manufacturers. Under new CEO Wendy Barnes, who joined in January, it partnered with Novo Nordisk to offer discounted GLP-1s at pharmacy counters. The news sent GoodRx's stock up 37% that day. In her comments to Endpoints, Jensen said that pharma solutions is the company's fastest-growing segment by revenue. Some areas, like GLP-1s, are experiencing a larger mix of cash-pay interest, and she's watching to see whether that translates into other drug categories... Sub. Req’d

Pharmacists: Upfront Pharmacy Discounts Essential To IRA Program

(11/4, Gabrielle Wanneh, Inside Health Policy) ...The American Society of Health-System Pharmacists, the Hematology/Oncology Pharmacy Association, the National Pharmaceutical Association and 38 other organizations argue the retroactive payment model favored by drugs companies is inconsistent with the intent of the Inflation Reduction Act's price negotiation program and inconsistent with the Trump administration's commitments to regulatory efficiency and health care price transparency. They say CMS has the legal authority to make drugmakers change their approach... Sub. Req’d

340B Rebate Model Pilot Maintains CMS' Duplicate Discount Position

(11/4, Cathy Kelly, Pink Sheet) ...HRSA finalized 2026 340B rebate model pilot program implementation plans, but did not modify its position limiting instances when manufacturers can deny 340B discounts because they duplicate other federally-mandated concessions. The pilot still will increase transparency into 340B claims, a long-sought goal for pharma. Manufacturers hope the pilot will be rapidly expanded to encompass all 340B-eligible drugs and not just those subject to Medicare negotiated prices in 2026... Global Sub. Full

The Middlemen Draining Main Street Pharmacies

(11/4, Justin Leventhal, RealClearHealth) ...The bottom line is simple: patients—especially those in underserved areas—need local pharmacies to stay open. Independent pharmacists play a vital role in our communities, offering competition that can play a vital role in keeping drug prices in check. By forcing PBMs to operate in the open and by allowing alternative supply channels, we can restore a competitive market. In that market, PBMs would be rewarded for helping pharmacies thrive and patients save money—and punished for gouging drug costs. Market-based PBM reforms will protect patients' access to medicine and give them the full benefits of competition... Full

I Watched Science Change The World. Here's What Could Stop It.

(11/4, Mark L. Rohrbaugh, Health Affairs) ...Yet today, the Bayh-Dole framework is under attack. Critics argue the government should use a narrow clause in the law—so-called "march-in rights"—to relicense patents on brand-name drugs to generic manufacturers, which could produce cheaper knock-off versions. That's not what the clause was designed for. March-in rights exist as a backstop for four specific scenarios outlined in the legislation—none of which are related to the price of a resulting product... Full

PhRMA Calls on USTR to Ensure Foreign Nations Pay Their Fair Share

(11/4, Brian Picone, PhRMA) ...Our ask: America's biopharmaceutical innovators depend on policies that protect IP rights and provide market access to deliver new medicines to patients. The U.S. government should work to eliminate foreign trade barriers that undermine this important mission... Full

Inspection Readiness Remains Top-of-Mind –With Adjusted Focus

(11/4, Linda Evans O'Connor, Lachman Consultants) ...With a new U.S. administration and leadership at HHS, regulatory priorities have evolved over the course of 2025. While the exact current and potential future priorities of the FDA may not be fully known at this point, one can expect continued focus on compliance, product quality, and supply-chain resilience, making it crucial for pharmaceutical and biologics manufacturers to stay ahead of regulatory expectations and always be inspection ready. Here are some things to keep in mind as we continue our way into the FDA's new fiscal year... Full

Tidmarsh Furor Is Latest Blow To Credibility Of FDA Decision-Making

(11/4, Jessica Karins, Inside Health Policy) ...Allegations that George Tidmarsh used his position as FDA's top drug regulator to pursue a "vendetta" against a former business associate are likely to cast an additional pallor over an agency already facing skepticism from industry over a number of controversial drug decisions. Several companies have publicly said rejections of their applications came as surprises that contradicted previous communications with reviewers, and some FDA observers say the agency looks more like a political body than a neutral regulator under Commissioner Marty Makary... Sub. Req’d

Pharma Groups Seek Expansion of FDA's PreCheck Program

(11/4, Joanne S. Eglovitch, Regulatory Focus) ...Numerous pharmaceutical industry groups are advocating for the expansion of the US Food and Drug Administration's (FDA) PreCheck program to cover existing manufacturing facilities, as well as new ones. Additionally, some groups recommend that PreCheck be integrated with current programs. The generic drug industry has also suggested that other government initiatives and support should be implemented to strengthen this sector... Full

After Colorado Put a Price Cap On its Drug, Amgen Sued the State Board that Did It. Again.

(11/5, John Ingold, The Colorado Sun) ...Amgen said the price cap, which is formally called an upper payment limit, is unconstitutional and will cause the company financial damage. "Amgen will suffer substantial, irreparable harm as a result of Colorado's imposition of an upper payment limit on Enbrel," the company writes in its lawsuit, which was filed in U.S. District Court in Denver on Thursday. The company is represented by attorneys based in Colorado and in Washington, D.C., with the firm King & Spalding... Full

Medincell: UZEDY® Continues Strong Growth; Teva Setting the Stage for US NDA Submission for Olanzapine LAI in Q4 2025

(11/5, Medincell) ...Medincell's partner Teva Pharmaceuticals shared today the following information: About Olanzapine Long-Acting Injectable (TEV-749 / mdc-TJK)...Estimated 20% to 30% of patients on oral olanzapine are potential candidates for LAI. Absence of required monitoring expected to drive Olanzapine LAI usage growth. U.S. NDA3 submission planned for Q4 2025. Following an NDA submission, the FDA takes approximately 2 months to determine acceptance for review, followed by an additional 8 months for a standard review, which may lead to approval in late 2026... Full

Johnson & Johnson Reinforces its Leadership in Hematology at ASH 2025 Unveiling New Paradigm-Shifting Research

(11/4, Johnson & Johnson) ...Johnson & Johnson, a worldwide leader in hematology, today announced more than 46 poster presentations and 10 oral presentations on hematologic malignancies and other blood disorders will be presented at the 67th American Society of Hematology (ASH) Annual Meeting from December 6–9, 2025, in Orlando, Florida. Results will showcase practice-influencing evidence from across the Company's diverse hematology portfolio and progress towards advancing next-generation therapies... Full

FDA Rejects Biohaven Approval Request for Troriluzole, Triggering R&D Cost Cutting

(11/5, Nick Paul Taylor, Fierce Biotech) ...The FDA has rejected Biohaven's request for approval of a neurological disorder therapy, prompting the biopharma to reprioritize its pipeline in order to shrink its annual R&D spend by 60%... Full

Teva Recalls More Than Half-a-Million Bottles of Blood Pressure Drug Over Potential Carcinogens

(11/4, Joseph Keenan, Fierce Pharma) ...Teva has issued a voluntary recall of more than 500,000 bottles of the widely used blood pressure medication prazosin hydrochloride, citing unacceptable levels of potentially cancer-causing impurities... Full

FDA Recalls 580K Bottles of This Blood Pressure Medication: Is Your Medicine on The List?

(11/4, Katherine Rodriguez, NJ.com) ...Teva has issued a voluntary recall of more than 500,000 bottles of the widely used blood pressure medication prazosin hydrochloride, citing unacceptable levels of potentially cancer-causing impurities... Full

Alvotech Plant Issues Foil Another FDA Review, This Time for Teva-Partnered Simponi Biosimilar

(11/4, Fraiser Kansteiner, Fierce Pharma) ...Patients hoping to get their hands on a cheaper copycat of Johnson & Johnson's fading anti-inflammatory blockbuster Simponi may have to wait for a few months more, thanks to an FDA inspection this summer that has derailed a leading biosimilar application from partners Teva and Alvotech. The FDA has issued Alvotech a complete response letter (CRL) on the candidate, coded AVT05, snubbing the company's application for both a prefilled syringe and an autoinjector biosimilar to Simponi, which also goes by the generic name golimumab... Full

‘Like A Kid In A Candy Store' – Sandoz Sets Out Its Next Steps In Biosimilars

(11/4, Dave Wallace, Generics Bulletin) ...Sandoz CEO Richard Saynor has said the company is "almost a kid in the candy store" when it comes to evaluating the next pipeline opportunities for its booming biosimilars business. In terms of potential targets for biosimilars, Saynor sees "way more opportunity than there is financial firepower for any company to develop." Although the year is almost over, Sandoz plans four more major biosimilar launches before the end of 2025. With its biosimilars still experiencing double-digit sales growth and contributing to a favorable product mix, Sandoz has raised its full-year guidance. Despite the focus on biosimilars, Sandoz still sees plenty of value in small-molecule generics, which make up half of the loss-of-exclusivity opportunity on the horizon... Global Sub. Full

Daewoong Showcases Microneedle, Biosimilar Tech at CPHI Worldwide 2025

(11/5, Lee Han-soo, Korea Biomedical Review) ...Daewoong Pharmaceutical said it participated in the world's largest pharmaceutical exhibition, CPHI Worldwide 2025, held in Frankfurt, Germany, from Oct. 28 to 30, to highlight its next-generation drug delivery and biosimilar technologies as part of its global expansion strategy...During the event, Daewoong introduced its flagship innovative drugs, including Fexuclue (fexuprazan) and Envlo (enavogliflozin), alongside advanced formulation platforms such as GLP-1 microneedle patches and biosimilars, while pursuing new partnership and licensing opportunities... Full

Marksans Pharma UK Arm Gets Marketing Nod For Exemestane 25mg Film-Coated Tablets

(11/5, Ruchika Sharma, Medical Dialogues) ...Marksans Pharma Limited's wholly owned subsidiary in UK, Relonchem Limited has received marketing authorization for its product Exemestane 25mg film-coated tablets from UK Medicines and Healthcare products Regulatory Agency... Full

14 Drugs in Shortage

(11/4, Ella Jeffries, Becker's Hospital Review) ...Here are 14 recent drug shortages and discontinuations, according to FDA drug supply databases... Full

India's Top Drugmaker Sun Pharma Beats Profit View On Strong Domestic Demand

(11/5, Kashish Tandon, Reuters) ...Sun Pharma has been focusing on strengthening its portfolio of innovative drugs in dermatology, oncology and obesity therapy areas as it focuses on a mid-to-high single digit percentage revenue growth in the current fiscal year. Sales of the drugmaker's global innovative drugs, which is the company's high-margin segment and includes medicines for conditions such as alopecia and psoriasis, rose nearly 16.4% to $333 million. U.S. sales of innovative medicines have surpassed generics for the first time during the quarter, Kirti Ganorkar, the drugmaker's managing director, said... Full

Novo Nordisk's Medicare Deal Takes Heat Off Wegovy Slowdown

(11/5, Jacob Gronholt-Pedersen, Maggie Fick, Bhanvi Satija, Reuters) ...Wegovy-maker Novo Nordisk trimmed its full-year profit and sales forecasts on Wednesday as sales growth slows, but investors cheered a better-than-expected Medicare pricing deal that helped lift the shares after an initial slide. Novo is going through a tumultuous period marked by a share price plunge and slowing sales growth, which have prompted a change of CEO and a board shake-up. It's also in a bidding war with U.S. rival Pfizer for biotech Metsera... Full

Ozempic Maker Novo Nordisk Lowers Growth Outlook for its Weight Loss Drugs as Pricing Pressures Mount

(11/5, Tasmin Lockwood and Chloe Taylor, CNBC) ..."While we delivered robust sales growth in the first nine months of 2025, the lower growth expectations for our GLP-1 treatments have led to a narrowing of our guidance," Mike Doustdar, president and CEO said in a statement. Doustdar, speaking to CNBC's Charlotte Reed in an interview from Novo's headquarters, added that the firm's obesity drugs serve one million patients in the U.S., which is a third of the market "everyone is fighting" over... Full

Pfizer ‘Unwavering' In Pursuit Of Metsera

(11/4, Jessica Merrill, Scrip) ...Pfizer is not backing down from a bidding war with Novo Nordisk for the obesity drug developer Metsera, a topic that dominated Pfizer's third quarter sales and earnings call on Nov. 4, even as Metsera determined another offer from Novo to be "superior." The competitive dynamics in obesity, expected pricing pressure for obesity drugs and lack of late-stage clinical trial data for Metsera's assets led some analysts to press CEO Albert Bourla if Metsera is worth the trouble. "Our belief in the promise of the Pfizer and Metsera combination is strong and unwavering," Bourla said. "We are confident it will create substantial value for shareholders and advance innovation to bring important medicines to patients in the high-growth therapeutic area of obesity."... Global Sub. Full

Fresenius Raises Earnings Guidance After Another Quarterly Beat

(11/5, Tristan Veyet, Patricia Weiss, editing by Milla Nissi-Prussak, Reuters) ...Germany's Fresenius raised its annual operating profit guidance after it once again topped analysts' earnings expectations on Wednesday, as the healthcare group carries out the second part of its turnaround plan. Fresenius has been consistently beating earnings forecasts in recent quarters, helped by CEO Michael Sen's organisational revamp aimed at reducing costs and liabilities. That plan included ceding control of dialysis firm FMC in 2023... Full

As Pharma Pour Billions in US Manufacturing, CDMOs See Future Opportunities

(11/4, Anna Brown, Endpoints News) ..Endpoints News spoke with CEOs on the sidelines of the Convention on Pharmaceutical Ingredients confab in Frankfurt, who said that pharma companies may be overinvesting in their US footprint, which could provide acquisition opportunities for CDMOs in the future. Since early this year, over $480 billion in investments have been pledged to the US as President Donald Trump continues to threaten pharma-specific tariffs. Most recently, Trump warned companies that they needed to start breaking ground in the US or face 100% tariffs, causing them to rush to start construction... Sub. Req’d

Is Mark Cuban Wrong About Employers, PBMs and Drug Prices?

(11/4, Arundhati Parmar, MedCity News) ...The billionaire Mark Cuban whose Cost Plus Drugs company has been shaking up the world of prescription drug coverage minces no words when it comes to the role of employers in bringing down healthcare costs. But some employers believe he is wrong... Full

Britain's Plan to Raise NHS Drug Prices Won't Bring Back Lilly's Investment

(11/5, Helen Collis, Caroline Hug, Politico) ...The U.S. president has demanded lower drug prices for Americans, and suggested other developed countries should pay more. The British plans under consideration could increase the threshold at which the NHS pays firms for medicines by up to 25 percent. But for the U.S. pharmaceutical company — which shelved its planned facility meant to support early-stage life sciences businesses with lab space, mentorship and potential financial backing — the proposal alone is not enough. "I don't think we have heard enough to say that we are willing to get the Lilly Gateway Lab started," Patrik Jonsson, president of Lilly's international business, which covers all markets outside the U.S., told POLITICO... Full

Australia's Tony Lawler Takes Charge of International Regulatory Coalition

(11/4, Neena Brizmohun, Pink Sheet) ...Tony Lawler, head of Australia's Therapeutic Goods Administration, became the new chair of the International Coalition of Medicines Regulatory Authorities on Oct. 23. He took over the role from the European Medicines Agency's Emer Cooke, who held the position for five years. The ICMRA is a global alliance of over 40 medicines regulators that collaborate to share information, address current and emerging safety challenges, and promote regulatory harmonization... Global Sub. Full

Bayer Eyes Deeper Cooperation with Chinese Innovators in Pharma, Agriculture

(11/5, Zheng Yiran and Ouyan Shijia, China Daily) ...Matthias Berninger, executive vice-president, head of Public Affairs, Sustainability and Safety at Bayer AG, highlighted China's tremendous progress in life sciences, stating the country has become "amongst the leading nations" in pharmaceutical innovation. "China-led innovation is becoming attractive for global pharmaceutical companies including Bayer," he said in an exclusive interview with China Daily... Full

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