Three gener­ic firms shell out $447M more to set­tle fed­er­al price fix­ing al­le­ga­tions

Gener­ic drug firms Taro Phar­ma­ceu­ti­cals USA, No­var­tis’ San­doz, and Apo­tex have agreed with the US De­part­ment of Jus­tice to pay $447.2 mil­lion on top of the more than $400 mil­lion in crim­i­nal penal­ties they al­ready paid to re­solve al­leged vi­o­la­tions that they il­le­gal­ly col­lab­o­rat­ed on price, sup­ply and al­lo­ca­tion of cus­tomers with oth­er phar­ma man­u­fac­tur­ers.

Each of the com­pa­nies en­tered a five-year cor­po­rate in­tegri­ty agree­ment, which in­cludes in­ter­nal mon­i­tor­ing and price trans­paren­cy pro­vi­sions, among oth­er checks and bal­ances.

New York-based Taro will pay al­most half of that lat­est sum, or $213.2 mil­lion, for al­leged vi­o­la­tions in­volv­ing the non­s­teroidal drug etodolac, and nys­tatin-tri­am­ci­nolone cream and oint­ment to treat skin in­fec­tions.

San­doz agreed to pay $185 mil­lion re­lat­ed to al­leged is­sues with be­nazepril HCTZ, used to treat hy­per­ten­sion, and clo­be­ta­sol, a cor­ti­cos­teroid used to treat skin con­di­tions.

“The con­duct at is­sue here oc­curred at San­doz from March 2013 through De­cem­ber 2015 in di­rect con­tra­ven­tion of the com­pa­ny’s val­ues, poli­cies and train­ings in place at the time. The in­di­vid­u­als im­pli­cat­ed in the un­der­ly­ing con­duct are no longer em­ployed by the com­pa­ny,” San­doz said in a state­ment.

And Flori­da-based Apo­tex agreed to pay $49 mil­lion in con­nec­tion with its sale of pravas­tatin, a drug used to treat high cho­les­terol and triglyc­eride lev­els. Apo­tex is al­so part of an­oth­er on­go­ing in­ves­ti­ga­tion in­volv­ing pravas­tatin price-fix­ing al­le­ga­tions, in­volv­ing Te­va Phar­ma­ceu­ti­cals and Glen­mark Phar­ma­ceu­ti­cals.

This lat­est $447 mil­lion pay­out al­so fol­lows the pay­ment of sep­a­rate crim­i­nal penal­ties, in which Taro paid $205.6 mil­lion and ad­mit­ted to con­spir­ing with two oth­er gener­ic drug com­pa­nies to fix prices on cer­tain gener­ic drugs, while San­doz paid an­oth­er $195 mil­lion and ad­mit­ted to con­spir­ing with four oth­er gener­ic drug com­pa­nies to fix prices on cer­tain gener­ic drugs, and Apo­tex paid $24.1 mil­lion and ad­mit­ted to con­spir­ing to in­crease and main­tain the price on pravas­tatin.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Up­dat­ed: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long-term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more reimbursement, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. That’s a far cry from the peak Wall Street sales estimate of about $9 billion in annual sales, and even a ways away from the sell-side consensus of about $17 million in Q3 sales.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Eli Lil­ly or­dered to pay roy­al­ties on block­buster di­a­betes drugs, though ex­act dam­ages are un­clear

A federal court found Eli Lilly in breach of a royalty agreement with an Arizona company, likely sending the case — which deals with Lilly’s blockbuster diabetes drugs — to a trial.

The Arizona District Court ordered Lilly to pay the royalties to Tucson, AZ-based Research Corporation Technologies, per an opinion delivered Tuesday, stemming from a 1990 agreement involving materials used in manufacturing Lilly’s insulin products. Lilly had agreed to pay a 2% royalty on worldwide sales, and the exact amount of damages will be determined in a trial, Judge Scott Rash wrote.

Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.