Watchdog: HHS Failed To Properly Incentivize Development Of Antibiotics In Era Of Superbugs

Stat: Watchdog Scolds HHS For Lacking Plan To Incentivize Antibiotic Development
Amid growing anxiety over a lack of antibiotics, a new report from a Congressional watchdog found that the Department of Health and Human Services lacks an overarching strategy for developing new incentives to manufacturers. In particular, the Government Accountability Office argued in a new report that the HHS so far hasn’t agreed about the need to offer certain types of so-called pull incentives, which could be offered to companies to help cover manufacturing and marketing costs after antibiotics have been approved by the Food and Drug Administration and reached the market. (Silverman, 4/29)

Stat: Orphan Drugs Improve Health — But Aren't Priced Cost-Effectively
As regulators approve a growing number of orphan drugs, prices for these medicines, which treat small groups of patients with rare diseases, have been climbing ever higher. And a new study finds that, while the drugs may offer larger health gains than other medications, they are not nearly as cost-effective. (Silverman, 5/4)

Stat: With Remdesivir, Gilead Finds Itself At Strategic Crossroads
Never in modern times have such high hopes for millions of lives rested on one single company. As the world struggles to fight off Covid-19, Gilead Sciences has been thrust in the spotlight with remdesivir, the antiviral drug that on Friday the Food and Drug Administration gave emergency authorization to treat coronavirus patients. Doctors are already preparing for a surge of requests from potential patients. Anthony Fauci, the nation’s top infectious disease expert, is sounding close to buoyant. The markets are showing signs of recovery. And President Trump, who has vilified the drug industry since before his election, welcomed Gilead CEO Daniel O’Day to the Oval Office. (Florko and Garde, 5/5)

Bloomberg: Anti-Malaria Drug Hydroxychloroquine Coronavirus Demand Plunges
President Donald Trump has stopped talking about the decades-old antimalarial drug he once touted as a “game changer” for Covid-19, but it won’t be as simple for the rest of the health system to just move on. When Trump first began touting the drug in mid-March, a frenzy ensued as hospitals, patients and doctors raced to secure supplies. Many believed even if the drug didn’t turn out to be an effective coronavirus treatment, it might be able to ward off infection. (Edney, 5/5)

Modern Healthcare: Insurers Deny 25% Of Medication Claims For Infant Respiratory Illness
Respiratory syncytial virus, or RSV, contributes to about 57,000 hospitalizations among children younger than five each year in the U.S. Virtually all children will get the infection before they are two and most of the time the symptoms are mild but in severe cases it can lead to bronchiolitis or pneumonia. There is no vaccine for RSV but the medication palivizumab is recommended for use by the American Academy of Pediatrics among infants born before 29 weeks or infants with congenital heart disease or chronic lung disease because they are vulnerable to severe cases of the virus. Despite its recommended use, 25% of palivizumab prescriptions for babies born before 29 weeks gestation were denied by commercial insurers from January to December 2019, according to a report from the not-for-profit Institute for Patient Access. The analysis includes 1,031 commercial claims. (Castellucci, 4/28)

Stat: The Cost Of Some Cancer Drugs Doesn't Line Up With The Benefit
As payers increasingly demand good value for medicines, a new analysis found that costs for dozens of cancer drugs in the U.S. were 2.3 times higher than in four wealthy European nations. And at the same time, there was generally no association between the clinical benefits of the drugs and the monthly treatment costs in most of the countries. (Silverman, 4/30)

Bloomberg Law: Generic Drug Decisions Stall As Virus Forces Patent Court Delays
Patients with cancer, kidney disease, and other ailments could pay higher drug prices for months longer than they otherwise would thanks to court delays caused by the coronavirus outbreak. At least six patent infringement lawsuits over brand-name drugs are at risk of surpassing—or are already set to exceed—Food and Drug Administration timelines for approving generic versions, according to a Bloomberg Law analysis of court dockets. Depending on how long the pandemic goes on, that list could grow. (Bauman, 5/4)

Stat: Biogen’s Blockbuster Rare Disease Drug Could Be In Trouble
The success of Biogen’s spinal muscular atrophy treatment Spinraza has been among the few bright spots in a trying few years for the company. But new data from a competing medicine suggests diminishing returns in the future, a problem that could be exacerbated by the coronavirus pandemic. (Garde, 4/29)

Bloomberg: Bayer CEO Werner Baumann Wins Investor Vote Amid Roundup Talks
Bayer AG’s chief executive officer won a key confidence vote from shareholders, a show of support that eluded him last year and affirms his efforts to pull the company out of the Roundup crisis. About 93% of shareholders gave their backing to Werner Baumann and other managers. The positive result is typically a foregone conclusion in corporate Germany, but the CEO lost the vote last year as shareholders revolted over the fallout of the $63 billion Monsanto takeover. (Loh, 4/28)

Bloomberg: AbbVie Wins U.S. Antitrust Nod For Botox Maker Allergan
AbbVie Inc. won U.S. antitrust approval for its acquisition of botox maker Allergan Plc, clearing the last major hurdle from competition regulators to the $63 billion deal. The companies said Tuesday that the Federal Trade Commission approved the takeover after they agreed to sell assets to AstraZeneca Plc and Nestle SA to resolve competition concerns from the tie-up. (McLaughlin, 5/5)

Bloomberg: German Drugmaker Stada Seals Deal To Sell Cough Syrup In China
Stada Arzneimittel AG has signed a partnership agreement with a unit of Shijiazhuang Yiling Pharmaceutical Co. to sell its cough and cold syrups in China. The cooperation will help Stada, which is owned by private-equity firms Bain Capital and Cinven, as it seeks to expand in the country, according to Carsten Cron, the German drugmaker’s executive vice president for emerging markets. Along with selling the locally-produced syrups in the world’s most populous country, the partnership will enable Stada to pursue a strategy in China’s e-commerce market for consumer health care brands, and for Stada and Yiling Pharmaceutical to jointly develop high-potency raw materials, he said. (Baigorri, 4/29)