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FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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As drug­mak­ers spend $6B an­nu­al­ly on DTC ads, sen­a­tors re­vive bill to in­clude list prices in ads

A new GAO report on biopharma companies’ $6 billion annual spending on direct-to-consumer advertising is pushing US Senate Majority Whip Dick Durbin (D-IL) and Sen. Chuck Grassley (R-IA) to reintroduce legislation that would require price disclosures in the ads.

The GAO found that drugmakers spent almost half—$8.2 billion of the $17.8 billion from 2016 to 2018—on DTC ads for drugs in three therapeutic categories, including inflammatory conditions (e.g., arthritis, gout), endocrine and metabolic disorders (e.g., type 2 diabetes, hypothyroidism), and conditions affecting the central nervous system (e.g., depression, multiple sclerosis), according to the new report.

As spot­light trains on bio­phar­ma di­ver­si­ty, most com­pa­nies kept their C-suites ex­act­ly the same in 2020 — re­port

The past year has cast a harsh spotlight on the biopharma industry’s lack of diversity. And though most companies list diversity and inclusion as one of their key values, a whopping 67% of companies saw little or no change in representation by race or ethnicity at the executive level, according to a recent BIO survey.

As part of its second annual diversity report, BIO partnered with Coqual (formerly known as Center for Talent Innovation) to survey 100 companies from October to December 2020. They received organization-level diversity data from 18 companies, and executive-level diversity data from 16. Seventy percent of respondents listed D&I as one of their stated values, BIO said. But only 13% actually increased representation for executives of color by at least 5%.

Bay­er clos­ing down San Fran­cis­co re­search hub as at­ten­tion turns to Berke­ley plan

Bayer is saying farewell to a longtime research hub in San Francisco, centralizing US efforts in the Boston area and potentially leaving several biotechs in its incubator without a home.

The German drug giant will shut down the “innovation hub” and CoLaborator incubator ahead of its lease expiring in October, a Bayer spokesperson told Endpoints. Once a location thought of as pivotal to Bayer’s US plans, the San Francisco site will shutter after more than a decade of operation.

Med­ic­aid com­mis­sion to Con­gress: In­crease re­bates for ac­cel­er­at­ed ap­proval drugs

As the FDA continues to approve more new drugs under its accelerated approval pathway, the non-partisan Medicaid and CHIP Payment and Access Commission (MACPAC) is telling Congress to increase the statutory Medicaid rebates for such drugs until their clinical benefits have been verified.

Higher rebates for drugs with accelerated approvals, a move opposed by the biopharma industry, would mean lower net prices, lessening their financial burden on the health care system while incentivizing the companies to speed the verification of the drugs’ clinical benefits in confirmatory trials. Once those benefits are confirmed, the companies would return to the lower rebates when the accelerated approval is converted into a full approval, MACPAC suggests.

Kodak CEO Jim Continenza (R) with ex-Development Finance Corporation CEO Adam Boehler (DFC)

UP­DAT­ED: The Ko­dak in­sid­er trad­ing dra­ma con­tin­ues as CEO set for ques­tion­ing in NY state probe

The state of New York’s insider trading probe into camera maker Kodak appeared to heat up Tuesday as the company’s CEO and general counsel have been ordered to publicly testify.

Kodak and chief Jim Continenza are accused of breaking state security laws after Continenza allegedly bought tens of thousands of shares in anticipation of landing a $765 million government contract from former President Donald Trump’s administration last July.

Amid slug­gish sales and du­el­ing law­suits, No­var­tis bows out of Am­gen part­ner­ship, slash­es staff

When Novartis and Amgen got Aimovig approved in 2018, most migraine patients relied on decades-old, mildly effective pills to ease their headaches. Proven to reduce migraines by more than 50% in hard-to-treat patients, Aimovig was expected to quickly rake in over $1 billion per year.

In the three years since, though, a slew of rivals have entered: nearly identical treatments from Eli Lilly, Allergan, and Teva, alongside new oral options from Biohaven. Now, with competition tightening and relations between the two tense, Novartis is pulling out of the US market.

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Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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Geoffrey Porges, SVB Leerink

Top an­a­lyst maps a rocky road for Ver­tex — un­less they adopt a $10B M&A cam­paign to save the pipeline

After repeatedly poking Vertex $VRTX execs with pointed criticism of their R&D strategy, top SVB Leerink analyst Geoffrey Porges is now turning up the heat to a full-scale roasting.

In a note out early Monday morning, Porges spotlights the impact of Vertex’s recent follow-up failure on AATD — their treatment hit the endpoint but missed on commercial prospects — rewriting his recommended scenario for CEO Reshma Kewalramani as she grapples with the setback.

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In next-gen BTK bat­tle, Ab­b­Vie and J&J tout piv­otal da­ta back­ing Im­bru­vi­ca as a com­bo treat­ment

Last week, AstraZeneca took a swing at J&J and AbbVie’s first-generation BTK inhibitor Imbruvica in the blood cancer chronic lymphocytic leukemia with long-term data from a head-to-head trial. But the partners aren’t going down without a fight.

AbbVie and Janssen unveiled pivotal data on Saturday showing that first-line CLL patients who received Imbruvica and AbbVie’s Roche-partnered Venclexta lived longer without disease progression than patients on Gazyva and the chemotherapy chlorambucil. The Phase III GLOW trial enrolled 211 elderly patients, or those with comorbidities or concurrent illnesses. Overall, the median age was 71 years old.