Aim­mune says US gov­ern­ment shut­down stymied its peanut al­ler­gy drug ap­pli­ca­tion

As the longest gov­ern­ment shut­down in US his­to­ry en­dures the wrath of law­mak­ers on ei­ther side of the aisle, Aim­mune Ther­a­peu­tics $AIMT will bear the brunt of stretched funds at the FDA. Com­pa­ny man­age­ment — who sub­mit­ted their ap­pli­ca­tion to mar­ket their peanut al­ler­gy drug one day pre­ced­ing the shut­down — on Mon­day said the health reg­u­la­tor had no­ti­fied them that it would not be able to re­view the ap­pli­ca­tion un­til the lapse in ap­pro­pri­a­tions ends.

Aim­mune’s arch ri­val DBV Tech­nolo­gies $DB­VT said it had re­scind­ed an ap­pli­ca­tion to mar­ket its peanut al­ler­gy patch on De­cem­ber 20, af­ter the FDA ex­pressed con­cern about the state of man­u­fac­tur­ing and qual­i­ty con­trol da­ta sub­mit­ted. The fol­low­ing day, Aim­mune sub­mit­ted its ap­pli­ca­tion for peanut al­ler­gy im­munother­a­py AR101, in ef­fect leapfrog­ging its com­pe­ti­tion for a first-mover shot at cap­tur­ing the so far un­tapped mar­ket, which is ex­pect­ed to grow to $4.5 bil­lion in 2027 glob­al­ly, ac­cord­ing to Glob­al­Da­ta. The US shut­down be­gan on De­cem­ber 22 — af­ter Pres­i­dent Trump in­sist­ed on $5.7 bil­lion from Con­gress to build a wall on the south­west US bor­der.

In a se­ries of tweets on Mon­day, FDA com­mis­sion­er Scott Got­tlieb sug­gest­ed that ap­pli­ca­tions sub­mit­ted pri­or to the shut­down would be re­viewed, but that the agency was un­able to ac­cept user-fees to re­view any med­ical prod­ucts over the course of the lapse. Clar­i­fy­ing the FDA’s po­si­tion fur­ther, he tweet­ed lat­er in the day that blood prod­ucts and al­ler­genic prod­ucts are not cov­ered by user fee pro­grams, hint­ing that Aim­mune may have sub­mit­ted its ap­pli­ca­tion un­der the wrong path­way.

“Though this an­nounce­ment does set back the po­ten­tial ap­proval of AR101…any de­lay will, at worst, last as long as the shut­down but be­lieve that the break­through des­ig­na­tion and un­met need could re­sult in FDA ac­cel­er­at­ing a re­view time­line to re­main, more or less, in line with ex­pec­ta­tions for a 3Q19 ap­proval,” Baird’s Bri­an Sko­r­ney wrote in a note.

Mean­while, da­ta from a Eu­ro­pean Phase III tri­al eval­u­at­ing AR101 are ex­pect­ed in the first quar­ter of 2019.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Bris­tol My­ers Squibb sues No­var­tis for roy­al­ties sur­round­ing the use of trans­genic mice

Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.

Anthony Fauci (AP Images)

West Vir­ginia man faces prison time for threat­en­ing emails to Fau­ci, oth­er health of­fi­cials

NIAID director Anthony Fauci gained hero status amid the pandemic, earning Americans’ trust and even Time magazine’s Guardian of the Year title. But he and other federal health officials have also faced intense threats, according to charges brought by the US Department of Justice.

A West Virginia man is facing up to 10 years in prison after threatening Fauci, former NIH director Francis Collins, and HHS assistant secretary for health Rachel Levine via email, the DOJ said on Monday. Thomas Patrick Connally, Jr., pleaded guilty on Monday to using an anonymous email address to threaten the officials for performing their official duties, including discussing Covid-19 testing and prevention.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.