Big pharma’s off-patent drugs lose out in China’s new price-cutting scheme

In a Battle of Waterloo-style defeat, off-patent drugs from big pharma firms lost major markets in China as the government adopted a novel procurement scheme to slash generic drug costs. But after steep price cuts, local firms aren’t considered winners, either. In the end, only AstraZeneca’s EGFR inhibitor Iressa and Bristol-Myers Squibb’s heart drug Monopril won their fights against local copycats.

Among the 31 drugs China’s newly formed health insurance watchdog listed for procurement in a pilot program, multinational pharmas participated in bidding to supply almost all of them, but landed only two contracts, according to multiple local reports of preliminary tender results. (See more details on FiercePharma)

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Samsung BioLogics stock listing, CEO in jeopardy over accounting fraud

South Korean stock regulators have ruled that Samsung BioLogics intentionally violated accounting rules to inflate its value tied to its Biogen-partnered affiliate Samsung Bioepis before going public in 2016. Based on that, the country’s Securities and Futures Commission (SFC) has halted trading of the company on Wednesday, fined it 8 billion Korean won ($7.1 million), recommended dismissal of its chief executive Kim Tae-han and referred the case to prosecutors.

To make it worse, a review is underway that could eventually end in enforced delisting, which could be a serious blow to the fast-growing contract biologics manufacturer and to its parent Samsung Group.

In a Wednesday statement, Samsung BioLogics defended its practice, saying it followed related guidelines and that it will file an administrative lawsuit. (see more details on FiercePharma)

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AcelRx’s controversial under-the-tongue opioid nod sparks rare defense from FDA chief

Under the heat of an addiction epidemic is perhaps the worst of times to approve a new opioid in the U.S. But the FDA granted AcelRx’s sufentanil-based Dsuvia—ten times the strength of the already high-powered fentanyl—a green light anyway.

A 30 microgram sufentanil tablet that’s put under the tongue, Dsuvia is now approved to manage acute pain in adults, despite an outpouring of concerns over the drug’s potential role in the U.S. fight against the opioid crisis and even doubts about its efficacy and safety profile.

It was no ordinary FDA review, and not only because its Anesthetic and Analgesic Drug Products Advisory Committee chair, Raeford Brown, wrote a letter pleading with the agency to reject it. Commissioner Scott Gottlieb also made a rare separate statement to explain. But the noise around the approval didn’t stop AcelRx from planning a launch early next year or Jefferies analyst Roger Song from projecting more than $500 million in peak U.S. sales.

Here’s the twist: The opioid won’t be available at retail pharmacies for patients to take home. It must be administered by a healthcare professional in a medically supervised setting, such as hospitals and emergency rooms, under a restrictive risk-management plan mandated by the FDA.

That restriction could turn out to be a double-edged sword. On the one hand, it limits the drug’s uptake and hence sales, but on the other, as executives pointed out on the call, the drug poses low risk for potential abuse—a feature that could ease some public anxiety over yet another opioid option.

Lilly’s under-pressure Trulicity scores with first-of-its-kind cardio outcomes win

All eyes are on Eli Lilly’s Trulicity as it faces down some hefty new competition from diabetes rival Novo Nordisk. But the Indianapolis drugmaker just notched an important trial win that shows it can hang with its rival.

Monday, the pharma giant said that in a cardiovascular outcomes trial, Trulicity showed it could significantly cut down the combined rate of heart attack, stroke and cardiovascular death. It’s not the first drug to gain that distinction; fellow Lilly drug, SGLT2 Jardiance, grabbed that title in 2015, and since then plenty of other diabetes products—including Novo’s blockbuster GLP-1 Victoza and newer entrant semaglutide—have done the same.

Trulicity, though, is the first to demonstrate a reduction in a trial that included a majority of participants—about 69%—without already established cardiovascular disease, which “could help Trulicity differentiate” from other drugs’ outcomes studies, Credit Suisse analyst Vamil Divan wrote to clients. (see more details on FiercePharma)Trulicity

For pharma, a flipped House would be noisy, but real action? It’s all about the Senate

Midterm elections are underway, pharma watchers are keeping a close eye on the results, well aware that the industry has a lot at stake. Drug pricing has become a central issue in the election, and just who wins and loses in the Congressional races will determine how the industry fares for years to come. One favorable outcome for drugmakers, which many experts predict, is that Democrats will flip the House of Representatives, while Republicans will retain control of the Senate.

Anything can happen in elections, of course. But that scenario would be a positive for healthcare companies because it “likely means gridlock,” Cowen Washington Research Group healthcare and pharma managing director Rick Weissenstein wrote in a note to investors.

But while the drug pricing hearings would make “good theater,” like big tobacco hearings in the 1990s, Weisseinstein believes they wouldn’t bring about tangible change to pharma pricing dynamics. (see more details on FiercePharma)

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Pfizer manufacturing ills mean ongoing shortages for hospitals

Pfizer acknowledged Tuesday that it continues to struggle with manufacturing at some Hospira plants, an issue that bodes ill not just for investors but also for U.S. hospitals. The manufacturing problems at Hospira that dented earnings and led it to lower its forecast mean ongoing drug shortages for healthcare providers.

Manufacturing problems at Pfizer’s plant in McPherson, Kansas, are at the heart of some of the most troubling shortages for the the FDA and the healthcare system. Its Hospira unit is the largest producer of injectable opioid analgesics used in hospitals.

The FDA pointed out in a report that shortages of these particular drugs were caused by production delays tied to changes and upgrades made at a Pfizer facility in Kansas after the agency slapped it with a warning letter. It was then “exacerbated by recent issues related to manufacturing quality at the same facility.” The FDA has been working with Pfizer and other drugmakers to deal with the shortages.

Sanofi’s dengue shot Dengvaxia wins FDA priority review despite controversial past

Sanofi has weathered controversy with its world-first dengue vaccine, Dengvaxia, but the company is pressing ahead, and on Tuesday said the FDA had not only accepted its application for approval, but also granted a priority review.

The FDA is set to decide on Sanofi’s vaccine by May 1, 2019. In granting the priority review, the FDA determined the vaccine could be the first medical tool to prevent a serious disease with unmet need. Recipients would need to have confirmation of a prior dengue infection because of safety risks in those who haven’t, a Sanofi executive said, a factor that could complicate a broad rollout.

With an approval, officials could use the vaccine in the U.S. Virgin Islands and Puerto Rico, where the dengue burden is high, according to the company.  (see more details on FiercePharma)