Trump Wants To Bring Drug Manufacturing Back To United States. Pharma, Not So Much.

Stat: Pharma Panics As Washington Tries To Bring Drug Manufacturing To The U.S.
As the coronavirus pandemic disrupts global supply chains, lawmakers are increasingly calling on drug makers to exclusively manufacture medicines in the United States. But for a large swath of the pharmaceutical industry, that’s an existential threat. (Florko, 5/26)

The Wall Street Journal: Coronavirus Revives Debate Over Drug Pricing
Not long ago, drug companies had a bull’s-eye on their ticker symbols. Sky-high prices for lifesaving drugs and the opioid crisis had made them the country’s least-liked industry. Democratic presidential candidates were one-upping each other with promises to rein in prices, while President Trump mulled similar plans. Covid-19 has given drug companies a shot at redemption. They are pouring resources into therapies and vaccines, with the entire economy’s fate resting on their success. (Ip, 5/21)

The Wall Street Journal: Beware Buyer’s Remorse As Biotech Firms Rush To Sell Shares
Investor enthusiasm for biotechnology stocks is running hot. That could be a sign that the sector’s spring rally will soon wind down. A broad index of small and medium biotech stocks is just off record highs and has surged about 60% from the lows in March. The new reality of Covid-19, the disease caused by the coronavirus, has meant renewed interest in the sector, as some investors bet that the successful developer of a treatment or vaccine could eventually make huge profits. The outbreak has also meant fresh government funding for research and more latitude from regulators on requirements to get drugs to patients. (Grant, 5/21)

Reuters: Merck Leaps Into COVID-19 Development Fray With Vaccine, Drug Deals
Merck & Co Inc, which has largely kept to the sidelines of the race for COVID-19 treatments, said it was buying Austrian vaccine maker Themis Bioscience and would collaborate with research nonprofit IAVI to develop two separate vaccines. It also announced a partnership with privately held Ridgeback Biotherapeutics to develop an experimental oral antiviral drug against COVID-19, the respiratory disease caused by the novel coronavirus. It did not disclose the terms of the acquisition of Themis, a privately held company. (Steenhuysen and Erman, 5/26)

Stat: Argenx Drug Efgartigimod Improves Myasthenia Gravis Symptoms 
Argenx, a Belgian drug maker, said Tuesday that its experimental medicine improved the symptoms of patients with a rare neuromuscular disease, achieving the primary goal of a late-stage clinical trial. The positive study results will enable Argenx to seek U.S. approval before the end of the year as a potentially new treatment for patients with generalized myasthenia gravis, a chronic and debilitating condition in which the body’s own antibodies disrupt the communication between nerve endings and muscles. (Feuerstein, 5/26)

Stat: New Cancer Research Leader Brings Urgency To Sanofi
Peter Adamson joined Sanofi in late March, as the coronavirus pandemic surged around the world and changed lives and livelihoods. Someday, he says, he’ll take up his new role in Cambridge, Mass., as global development therapeutic area head for oncology in general and pediatric innovation in particular, but for now he is leading and learning from his home in South Jersey. (Cooney, 5/26)

Stat: Kadmon Sees Positive Results In Study On Pill For Graft-Versus-Host Disease
Kadmon Holdings, the New York-based biotech, said Thursday that its experimental pill for chronic graft-versus-host disease achieved all the efficacy goals of a late-stage clinical trial. Nearly 75% of the patients responded to treatment with the Kadmon drug, called KD025 — an improved result at the final analysis compared to interim findings disclosed last February. (Feuerstein, 5/21)

Stat: Startup Spotlight: Aiming To Speed Precision Cancer Therapies To Children
For some children with a certain type of brain tumor, treatment can mean surgery followed by multiple rounds of chemotherapy infusions to beat back the growth of their low-grade gliomas. A San Francisco startup hopes to change that trajectory with an oral therapy targeting specific proteins mutated in these cancers, part of a larger game plan to make precision treatments as available for kids with cancer as they are for adults. (Cooney, 5/21)

Bloomberg: Sanofi Adds Firepower In Exiting $13 Billion Regeneron Stake
Sanofi is selling a stake in Regeneron Pharmaceuticals Inc. valued at about $13 billion, giving the French drugmaker more firepower to potentially snap up promising assets in the cancer, gene therapy and rare-disease fields. The Regeneron exit, part of Sanofi Chief Executive Officer Paul Hudson’s revamped strategy to focus on fast-growing areas, is sparking speculation he’ll hunt for more targets following a deal in December to buy biotech company Synthorx Inc. for $2.5 billion. The transaction will boost Sanofi’s war chest to $50 billion, according to Bloomberg Intelligence. (Paton and Grffin, 5/25)

Stat: Experts Push For A 'Seal Of Approval' To Improve The Quality Of Medicines
Should there be a Good Housekeeping ‘seal of approval’ for prescription medicines? In a new paper, a group of academics and pharmacists argue that assigning scores based on a mix of regulatory actions and chemical analysis would motivate drug makers to produce more “quality” medicines and reduce shortages, while improving public health. (Silverman, 5/26)

Stat: Biosimilars Got The Cold Shoulder From Health Plans On Preferred Coverage
As debate rages over adoption of biosimilars in the U.S., a new analysis finds that 17 of the largest commercial health plans last year rarely preferred these versions of brand-name biologics when crafting coverage decisions. Specifically, the insurers made 535 coverage decisions last year for nine biosimilars that were available in the U.S. But the health plans required patients first try a biosimilar before gaining access to a brand-name biologic just 14% of the time. (Silverman, 5/20)

Stat: In A Tale Of Two Mercks, German Company Wins Court Fight Against U.S. Rival
In a setback for Merck (MRK), a court in London ruled that the big drug maker breached a decades-old agreement with Merck KGgA — an entirely different pharmaceutical company — and infringed on a trademark by using the name “Merck” in the United Kingdom. The ruling by the High Court of Justice, which follows an appeal of a similar decision four years ago, is the latest twist in a convoluted but heated battle between the two drug makers over their corporate nomenclature. (Silverman, 5/21)

Bloomberg: Biotech Tourists Drive Short-Lived Rallies In Covid-19 Stocks
The search for a Covid-19 cure and an end to global shutdowns has created a new type of investor in health-care stocks: the biotech tourist. They’re generalists who are “throwing money at headlines” about any Covid-19-tied companies that are generating “pockets of froth,” according to Brad Loncar, chief executive officer of Loncar Investments. Goldman Sachs analyst Asad Haider also pointed out concerns arising from mom and pop investors jumping into and then quickly exiting vaccine and drug developers on any sign of progress. (Flanagan, 5/26)

The New York Times: A Hidden Origin Story Of The CBD Craze
Long before CBD had become a trendy wellness elixir found in juice and moisturizer and ice cream and dog treats; before corporate chains like Walgreens and Sephora had decided to sell it; and way before Kim Kardashian West had thrown a CBD-themed baby shower, a ragtag crew of activists, doctors, writers and marijuana farmers met up on an early winter evening in 2011. They sat in a circle at a house in the hills a few hours north of San Francisco — where wine country becomes weed country — to discuss the therapeutic potential of CBD, and how to get people to take it seriously. (Lewis, 5/23)

Stat: Akorn Files For Bankruptcy Protection After Years Of Manufacturing Problems
After mounting financial and manufacturing woes, Akorn (AKRX) has filed for bankruptcy protection, a humbling move by a company that was on the verge of being purchased for $4.3 billion just two years ago. The filing follows a protracted period in which the drug maker haggled with lenders and fended off shareholder lawsuits, which were prompted after Fresenius Kabi walked away from a deal to buy the company. The acquisition fell apart after Fresenius found what it described as “material breaches” in manufacturing standards at Akorn facilities. (Silverman, 5/21)