Biden calls on Con­gress to al­low Medicare drug price ne­go­ti­a­tions

Over­shad­owed by Pres­i­dent Biden’s vac­cine man­date an­nounce­ment, the ad­min­is­tra­tion ear­li­er in the day re­leased its top pri­or­i­ties for drug pric­ing re­forms mak­ing their way through Con­gress.

The re­forms are slat­ed to save the gov­ern­ment hun­dreds of bil­lions to off­set oth­er spend­ing pri­or­i­ties.

The 29-page HHS re­port makes clear the ad­min­is­tra­tion’s strong de­sire for any leg­is­la­tion to in­clude Medicare drug price ne­go­ti­a­tions — an idea the phar­ma­ceu­ti­cal in­dus­try strong­ly op­pos­es — as well as mea­sures to slow price in­creas­es over time on ex­ist­ing drugs.

“A pro­vi­sion in the law that es­tab­lished the Medicare Part D pro­gram specif­i­cal­ly pro­hibits the HHS Sec­re­tary from in­ter­fer­ing with the ne­go­ti­a­tions be­tween drug man­u­fac­tur­ers and phar­ma­cies and plan spon­sors, re­quir­ing a par­tic­u­lar for­mu­la­ry, or in­sti­tut­ing a price struc­ture for the re­im­burse­ment of cov­ered Part D drugs,” the re­port says. “This re­stric­tion is unique to Part D and con­trasts with how drug prices are de­ter­mined in oth­er fed­er­al pro­grams, such as the use of ceil­ing prices in the VA and manda­to­ry re­bates in Med­ic­aid—both of which re­sult in low­er brand drug prices than in Medicare Part D.”

Peg­ging Medicare prices to what drug­mak­ers of­fer the VA is one of the top ideas be­ing float­ed by the Sen­ate Fi­nance Com­mit­tee, ac­cord­ing to a Stat News re­port. Sen­ate fi­nance chair Ron Wyden (D-OR) is ex­pect­ed to of­fer up a bill in the com­ing days that could set the course for what Con­gress ul­ti­mate­ly adopts when it comes to drug pric­ing re­forms.

Wyden has pre­vi­ous­ly em­pha­sized his de­sire to al­low Medicare to ne­go­ti­ate, al­though it re­mains un­known if all 50 Sen­ate De­moc­rats, all of whom will like­ly be need­ed for the bill’s pas­sage, are will­ing to back such an idea. Sens. Bob Menen­dez of New Jer­sey and Kyrsten Sine­ma of Ari­zona have pre­vi­ous­ly ex­pressed doubts.

SVBLeerink an­a­lyst Ge­off Porges said in a note this morn­ing, “from an in­dus­try point of view this pro­pos­al is an ex­is­ten­tial threat, and is like­ly to be fought tooth and nail. Giv­en the ten­u­ous ma­jor­i­ty for De­moc­rats in the House and Sen­ate, and the pri­or op­po­si­tion in the House to HR3, we be­lieve there is next to no chance that this ma­jor pil­lar of the plan gets through Con­gress.”

In the House, the En­er­gy & Com­merce com­mit­tee on Mon­day will be­gin mark­ing up its own drug pric­ing bill. That cur­rent­ly in­cludes Speak­er Nan­cy Pelosi’s HR 3, which the CBO has warned could put a damper on new drug de­vel­op­ment. But those pro­vi­sions could change de­pend­ing on the Sen­ate.

In con­junc­tion with Medicare ne­go­ti­a­tions, the ad­min­is­tra­tion en­cour­ages Con­gress to im­pose an ex­cise tax when man­u­fac­tur­ers raise the price of their prod­ucts faster than the rate of in­fla­tion, the HHS re­port adds, not­ing that Amer­i­cans spend more than $1,500 per per­son on av­er­age for pre­scrip­tion drugs and “pay prices that are far high­er than any com­pa­ra­ble na­tion.”

Oth­er pro­vi­sions from the re­port, such as in­creas­ing gener­ic drug and biosim­i­lar com­pe­ti­tion with fast FDA ap­provals, have been float­ed for years by mem­bers of Con­gress on both sides of the aisle.

But the ad­min­is­tra­tion al­so pledged its sup­port for so-called “skin­ny” la­bels, which have come un­der fire from courts re­cent­ly, and can al­low for gener­ic com­pe­ti­tion to come to mar­ket for some of the in­di­ca­tions of an ap­proved ref­er­ence prod­uct that aren’t un­der patent pro­tec­tion.

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi calls it quits on mR­NA Covid-19 shots, scrap­ping vac­cine from $3.2B Trans­late Bio buy­out

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

Brian Hubbard, Anji Pharmacetuticals CEO

Look­ing to rewrite the rules of drug li­cens­ing, start­up An­ji is on the hunt for 'dy­nam­ic eq­ui­ty' joint ven­tures

Licensing is one of the most common ways big drugmakers leverage biotech innovation to drive gains across their pipelines — and the structure of those deals is pretty well established. But one biotech with home bases in China and the US thinks it may have a better way.

On Tuesday, Cambridge-based biotech Anji Pharma closed a $70 million Series B with two late-stage molecules in the fold and a mission to rewrite the rules of drug licensing through what it calls “dynamic equity” deals and a joint venture-heavy game plan. The round was funded in whole by Chinese hedge fund CR Capital.

Ash Shehata, KPMG

As sup­ply chain wor­ries ease up, Big Phar­ma CEOs have a new top con­cern: re­cruit­ing and keep­ing em­ploy­ees

As the industry goes through a boom, Big Pharma’s CEOs seem to have realized one thing above the rest: It’s time to reward the people doing the leg work.

KPMG, a Big Four accounting network, has compiled a business confidence report for pharma CEOs for the past few years, and while 2020’s report had top executives soul-searching for answers and predictions amidst a chaotic time, it appears that some normalcy, coupled with the skyrocketing growth of the industry, has restored confidence levels at the top.

Con­tract re­search is hav­ing a mo­ment right now. Will M&A splash­es dri­ve the in­dus­try to even greater heights?

Contract research organizations are a fairly mysterious bunch. They’re typically considered the skilled laborers behind big drug development — the stage crews who run the trials behind some of the most (and least) successful data reveals in biopharma history.

But all that is changing.

This year, a couple of huge, out-of-the-blue M&A deals sounded the alarm on just how much money is flying around in this corner of the industry.

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