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☆ Explainer: After COVID and drug shortages, EU revamps drug laws
▼ + stars: | 2023-04-03 | by ( Maggie Fick | ) www.reuters.com time to read: +5 min

The Commission aims to publish a draft - the biggest overhaul of existing medical laws in two decades - on April 26. A Commission spokesperson said: "The Commission will put forward a balanced and patient-centred proposal, whilst fully supporting an innovative and competitive industry." If the EU health regulator approves a new use for the medicine, they get another year, bringing the total to 11. Fourteen member states have written to the Commission, criticising the idea as costly and harmful for consumers as it could disrupt the generic drugs market. Once the Commission publishes the draft, the European Parliament, Commission and member states will thrash out final details.

REUTERS/Daniel BecerrilLONDON, March 29 (Reuters) - Drugs that combat obesity could for the first time be included on the World Health Organization's "essential medicines list," used to guide government purchasing decisions in low- and middle-income countries, the U.N. agency told Reuters. A panel of advisers to the WHO will review new requests for drugs to be included next month, with an updated essential medicines list due in September. The request to consider obesity drugs was submitted by three doctors and a researcher in the United States. The majority – 70% - live in low- and middle-income countries. EXPANDING ACCESSIncluding obesity drugs among the WHO's essential medicines could have great significance for that population.

☆ Bausch Health's stock soars on solid quarterly results, but we have concerns about the recovery
▼ + stars: | 2023-02-23 | by ( Zev Fima | ) www.cnbc.com time to read: +4 min

Bottom line The Canadian specialty pharmaceuticals company reported solid results for the fourth quarter, along with favorable forward guidance. Bausch management on Thursday did not offer additional information, other than to reiterate its confidence in the strength of the company's patents. Bausch Health previously started the separation process via an initial public offering of Bausch + Lomb in May 2022. Results at the diversified products division — which includes neurology pharmaceutical products, generics and dentistry products — were hampered by generic competition. Notably, as Bausch Health owns most of Bausch + Lomb, the latter's financials still appear on Thursday's results.

☆ Novartis names Firmenich CEO as chairman designate of Sandoz
▼ + stars: | 2023-02-20 | by ( ) www.reuters.com time to read: 1 min

Companies Novartis AG FollowSandoz GmbH FollowZURICH, Feb 20 (Reuters) - Novartis (NOVN.S) on Monday announced the appointment of Gilbert Ghostine as chairman-designate of Sandoz, the generics unit Novartis wants to spin off later this year. Ghostine has been CEO of Geneva-based Firmenich, the world's largest privately owned perfume and taste company, since 2014. He will become the chairman of the new board at Sandoz, which is to be formed after its spin-off from Novartis in the second half of 2023, subject to final Novartis Board of Directors and shareholder approvals. Reporting by John Revill Editing by Paul CarrelOur Standards: The Thomson Reuters Trust Principles.

The Centers for Medicare and Medicaid (CMS) said it would test the models in the Medicare health program for people age 65 or over and the disabled and the Medicaid program for the poor. The agency also said it would work on developing a mandatory model for payment methods for drugs approved by the U.S. Food and Drug Administration (FDA) under its Accelerated Approval Program (APP). CMS will announce the first model's start date "as soon as operationally feasible", it said. Development on the Medicaid gene and cell therapy model will start in 2023 and launch for testing in 2026. The agency will start working with the FDA on the accelerated approval model in 2023 but has no planned launched date yet.

☆ Germany proposes to fix shortages in certain medicines
▼ + stars: | 2023-02-14 | by ( Ludwig Burger | ) www.reuters.com time to read: +2 min

FRANKFURT, Feb 14 (Reuters) - Germany's health ministry on Tuesday vowed to fix shortages in medicines for children, antibiotics and cancer drugs, proposing price increases for certain drugs, higher inventory levels and an early warning system. While countries around the world have reported shortages of antibiotics amid a wave of respiratory infections, the problem in Europe is particularly acute. According to the draft law, administered maximum prices for drugs designed for children up to the age of 12 as well as certain antibiotics and cancer drugs, can be increased by 50%. Drugmakers and hospital pharmacies would also have to keep larger stockpiles to buffer any temporary supply shortages. Over recent months, Germany has run into shortages of fever-lowering liquids for children, antibiotics and the commonly-used breast cancer drug tamoxifen, according to the national drugs regulator.

Much as he would have liked to significantly increase supplies, Biosca-Reig said he couldn't justify investing millions of euros in new production lines unless he was paid more for the generic drug to cover sharply rising costs. European generic drugmakers say the tender system and regulated prices have fuelled a race to the bottom, and European firms are being undercut by suppliers from Asia. BRUSSELS, WE HAVE A PROBLEMThe European Medicines Agency (EMA) and European Union lawmakers acknowledge there is a problem. Half the generic medicines sold in Spain are priced below 1.60 euros per box or bottle, the country's generics manufacturing association said. But companies with smaller market shares, such as Israel's Teva (TEVA.TA), which has 5% of the region's amoxicillin market according to Medicines for Europe, are constrained.

☆ Sanofi’s ailments are more than skin deep
▼ + stars: | 2023-02-03 | by ( ) www.reuters.com time to read: +2 min

LONDON, Feb 3 (Reuters Breakingviews) - Sanofi (SASY.PA) is battling multiple ailments. The $115 billion French pharma group on Friday forecast “low single digit” growth in earnings per share for 2023, disappointing analysts. Hence it’s more reliant on the star asthma and eczema drug Dupixent, which contributed nearly a fifth of Sanofi’s 43 billion euros of sales in 2022. Last August, $36 billion was wiped off Sanofi, GSK (GSK.L) and spinoff Haleon (HLN.L) shares on U.S. litigation fears. It currently trades on 10 times its forecast 2023 earnings, while Novartis (NOVN.S) trades on 13 times.

☆ Novartis says operating profit to grow again ahead of Sandoz spin-off
▼ + stars: | 2023-02-01 | by ( Ludwig Burger | ) www.reuters.com time to read: +2 min

Full-year core operating income was broadly flat at $16.7 billion, it said in a statement, coming in slightly below market expectations of $16.8 billion. Novartis shares were down 1.3% in early trade on Wednesday and have fallen about 11% since January 2020, underperforming most rivals. They were also disappointed by guidance for Sandoz's core operating income to decline by a "low double digit" percentage in 2023 due to cost inflation and investments to make it a stand-alone entity. MS drug Kesimpta, which requires fewer injections than standard therapies, is expected to become Novartis' second largest growth driver in 2023, after Entresto. Novartis shares lagReporting by Ludwig Burger; editing by Josephine Mason and Jason NeelyOur Standards: The Thomson Reuters Trust Principles.

☆ Novartis says operating profit to grow again ahead of Sandoz spin off
▼ + stars: | 2023-02-01 | by ( ) www.cnbc.com time to read: +3 min

Novartis on Wednesday predicted that core operating income would grow in a "mid single digit" percentage range in 2023 following stagnation last year, as the Swiss drugmaker prepares to spin off its Sandoz generics business. Full-year core operating income was broadly flat at $16.7 billion, it said in a statement, coming in slightly below market expectations of $16.8 billion. We're seeing health care systems stabilize a bit more, we're seeing China start to stabilize, and we see a second-half rebound in China. All of those are important tailwinds for a business like ours," he said during an interview in Basel, Switzerland. MS drug Kesimpta, requiring fewer injections than standard therapies, is expected to become Novartis' second largest growth driver in 2023, after Entresto.

☆ Pharma CEOs say Mark Cuban's effort to upend the drug industry is 'a really great idea' but will be difficult to pull off
▼ + stars: | 2023-01-25 | by ( Yeji Jesse Lee | Andrew Dunn | ) www.businessinsider.com time to read: +7 min

Biopharma CEOs say his company Cost Plus Drugs could remove costs from the distribution system. Cuban told Insider in an email that he believed the company's pricing transparency was "an absolute positive for patients." The company started its pharmacy services last year and quickly racked up over 1 million accounts, Cuban told Insider recently. Cost Plus Drugs is focused on bringing down the price of generic medications, which no longer have patent protections but can still be expensive. Cuban told Insider that EQRx was in a "different business" than what he's attempting to build out.

☆ Amazon launches $5-a-month unlimited prescription plan
▼ + stars: | 2023-01-24 | by ( Nathaniel Meyersohn | ) edition.cnn.com time to read: +3 min

New York CNN —Amazon is expanding its push into healthcare with a $5 monthly unlimited delivery pass on 60 common generic prescription drugs treating allergies, inflammation, high blood pressure and other conditions. Amazon announced the new delivery service, RXPass, on Tuesday and it will launch immediately in most states except California, Texas, Minnesota and others with specific prescription delivery requirements. The $5-a-month delivery pass is an add-on to Amazon Prime, Amazon’s $139 annual program, and is available exclusively to Prime subscribers regardless of their insurance status. Amazon has long offered a Prime prescription savings benefit to get discounts on generic and brand-name medications. Amazon’s new plan will mean consumers may see lower costs for some generic drugs, Nicholson said.

☆ Top pharma CEO says Covid likely to become endemic, urges investment in pandemic preparedness
▼ + stars: | 2023-01-19 | by ( Sam Meredith | ) www.cnbc.com time to read: +1 min

Novartis said in August that it plans to spin off its generics unit Sandoz to sharpen its focus on its patented prescription medicines. The chief executive of Swiss pharmaceutical giant Novartis on Thursday warned the coronavirus pandemic will likely settle into an endemic phase and renewed calls for policymakers to sufficiently finance pandemic preparedness. "If you look over the last two years, we have populations that have built up immunity, you have a virus that's continuing to make shifts, but I think what we're going to settle into is more of an endemic environment with respect to coronaviruses and the Covid virus specifically," Vas Narasimhan, CEO of Novartis, told CNBC at the World Economic Forum in Davos, Switzerland. Narasimhan, who has previously warned that future pandemics are bound to happen, made clear that world leaders must learn from the coronavirus crisis to be in a better place for future pandemics. "I think what is really important now is we turn our attention to pandemic preparedness for the future," Narasimhan said.

The problem was the Neris had switched to a new, high-deductible health insurance plan to save money. The 2010 Affordable Care Act expanded access to health insurance, so companies were faced with covering more people than ever before. But the epinephrine auto-injectors — which deliver a shot of epinephrine and are the only emergency medicine available for life-threatening allergic reactions — usually are not. But AHIP (formerly known as America’s Health Insurance Plans), a group that represents such companies, said drug manufacturers are to blame. Fight it with your health care provider, fight it with your insurance company.”“No almost never means no in health insurance,” he said.

☆ U.S. new drug price exceeds $200,000 median in 2022
▼ + stars: | 2023-01-05 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

The median annual price of the 17 novel drugs the U.S. Food and Drug Administration (FDA) approved since July 2022 is $193,900, down from $257,000 in the first half of 2022, Reuters found. For full year 2022, the median was $222,003. Reuters Graphics Reuters GraphicsIn 2021, the median annual price was $180,000 for the 30 drugs first marketed through mid-July, according to a study published recently in JAMA. Health insurers and other payers often demand discounts and rebates for prescription drugs once competing treatments become available. As patents expire, lower-cost generics also mitigate prescription drug price inflation, which in the 12 months through November 2022 was 1.9%, according to the Bureau of Labor Statistics.

☆ Novartis to pay $245 mln to end antitrust cases over Exforge drug generics
▼ + stars: | 2022-12-29 | by ( Jonathan Stempel | ) www.reuters.com time to read: +1 min

NEW YORK, Dec 28 (Reuters) - Novartis AG (NOVN.S) said on Wednesday it will pay $245 million to end antitrust litigation accusing the Swiss drugmaker of trying to delay the launch in the United States of generic versions of its Exforge hypertension drug. The class-action litigation stemmed from a 2011 licensing agreement between Novartis and Endo International Plc's (ENDPQ.PK) Par Pharmaceutical unit. Novartis's annual U.S. sales of brand-name Exforge exceeded $400 million before generic versions were sold, court papers show. The case is In re Novartis and Par Antitrust Litigation, U.S. District Court, Southern District of New York, No. Reporting by Jonathan Stempel in New York; Editing by Muralikumar Anantharaman and Bradley PerrettOur Standards: The Thomson Reuters Trust Principles.

The Mark Cuban Cost Plus Drug Company negotiates directly with drugmakers. So far, that's been the strategy for the Mark Cuban Cost Plus Drug Company. In October, Cost Plus Drug Company announced a partnership with Capital Blue Cross. Cuban said he wanted Cost Plus Drug Company to be as transparent as possible on pricing. Cost Plus Drug Company is considering a test program for insulin that would offer a 90-day supply of insulin, or a total of 12 vials, for $170.

☆ High demand for children's medications shines a light on fragile US drug supplies
▼ + stars: | 2022-12-12 | by ( Brenda Goodman | ) edition.cnn.com time to read: +13 min

Even when demand is not sky-high, drugs shortages happen regularly – but usually more quietly – in the US. At any time, the reasons why shelves may be empty vary from place to place and from drug to drug. With children’s medications, drug manufacturers say they are running full-tilt, and they planned for some increase in sales over the winter months. The FDA tracks drug shortages too, taking reports directly from manufacturers, but it defines them differently than the pharmacists’ group. The White House says drug shortages are a priority for President Biden’s administration, too.

☆ What to watch for as J&J gets ready to split into two separate companies next year
▼ + stars: | 2022-12-06 | by ( Paulina Likos | ) www.cnbc.com time to read: +11 min

During Monday's "Morning Meeting" for members, Jim Cramer said that J & J has the "best balance sheet in America." According to projections from J & J and rival Medtronic (MDT), the robotics market captures a low 2% to 3% of global procedures. In an economic slowdown, J & J is a solid name to own that can outperform the broader market. We also like that J & J has consistently raised its dividend. We rate J & J a 1 for the Club , meaning we would buy the stock at current levels given it aligns with our strategy.

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☆ World’s Top-Selling Drug Going Off Patent Means Big Bucks for Middlemen
▼ + stars: | 2022-11-27 | by ( David Wainer | ) www.wsj.com time to read: 1 min

AbbVie’s Humira has raked in about $200 billion over its lifetime. Starting next year the highest-grossing drug of all time, AbbVie ‘s Humira, will finally face competition from copycat biologics in the U.S. Yet the makers of the complex generics known as biosimilars won’t necessarily be the biggest winners. The top beneficiaries could instead be the middlemen such as Cigna and CVS Health , which will negotiate and dispense the drugs to patients.

Critical shortages of the ADHD drug Adderall and the antibiotic amoxicillin have left families reeling as the medicines their loved ones need become harder to find. In the case of amoxicillin, demand has become particularly acute amid a so-called tripledemic of Covid, respiratory syncytial virus, or RSV, and the flu that are converging this season. The Food and Drug Administration's website currently lists amoxicillin and Adderall, also known as mixed amphetamine salts, as being in short supply. NBC News reached out to two of the drugmakers responsible for producing both Adderall and amoxicillin. In 2020, Congress passed the Mitigating Emergency Drug Shortages Act, which aimed to address some of these issues.

One of the biggest makers of generic drugs, Israeli-based Teva said it aims eventually to secure a 10% global market share of biosimilars. A division of Novartis (NOVN.S), Sandoz is currently the second biggest player after Pfizer Inc (PFE.N) in the biosimilar market by gross sales globally, per IQVIA data, cited by Sandoz. Sandoz launched eight biosimilar drugs between 2017 and 2021, including a version of Bristol-Myers’ multiple myeloma drug Revlimid. The analysis projected the value of the global biosimilar market could more than triple to an estimated $74 billion by 2030. Sandoz and Teva are both working on biosimilars for Humira.

On social media, families say they’ve hunted for hours for Tamiflu and the first-line antibiotics amoxicillin and Augmentin. They have one viral illness after another. According to the US Centers for Disease Control and Prevention, more than half of US states have “high” or “very high” respiratory virus activity. As for the antibiotics amoxicillin and Augmentin – a combination of amoxicillin and clavulanate, an agent that helps guard against antibiotic resistance – it’s not entirely clear why demand is so high. Some viral illness, like influenza, can leave the body more vulnerable to secondary bacterial infections that may need treatment with antibiotics.

☆ Which to Choose: Medicare or Medicare Advantage?
▼ + stars: | 2022-11-20 | by ( Paula Span | ) www.nytimes.com time to read: +13 min

Which to Choose: Medicare or Medicare Advantage? Medicare Advantage plans, like traditional Medicare, are funded by the federal government, but they are offered though private insurance companies, which receive a set payment for each enrollee. The proportion of eligible Medicare beneficiaries enrolled in Medicare Advantage plans has hit 48 percent. Which is better: Medicare or Medicare Advantage? Credit... Kenny Holston for The New York Times Unlike most Medicare Advantage plans, traditional Medicare does not include drug coverage.

Most of the worst of respiratory illnesses remain concentrated in Southern states like Alabama, South Carolina, Tennessee and Virginia. There are signs that flu is ramping up in other areas such as Colorado, New Mexico and Texas, according to the CDC. Such widespread flu activity this early in the typical flu season hasn't been recorded in the U.S. in more than a decade. "We don't have any," a pharmacist in Charlotte, North Carolina, told NBC News, adding that the drug is on backorder, at least at her pharmacy. North Carolina's flu activity remains "very high" according to the latest CDC report.

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