A pharmacist at Whalen's Drug Store, 55 E 42nd Street, is shown putting up a sign advertising the fact that they now have the wonder drug, penicillin, in stock. However, New Yorkers soon learned that the potent germ killer cannot be bought across the counter like liver pills but only by prescription and that it must be administered by a physician. (March 1945 — via Getty Images)

FDA sur­vey finds Amer­i­cans don’t re­al­ly un­der­stand drug ap­provals

On­ly 25% of Amer­i­cans un­der­stand that a new drug ap­proved by the FDA does not nec­es­sar­i­ly mean the drug will help most peo­ple who use it, ac­cord­ing to the re­sults of a sur­vey con­duct­ed in 2017 and pub­lished last week in Phar­ma­coepi­demi­ol­o­gy & Drug Safe­ty.

How­ev­er, FDA’s sur­vey of a na­tion­al­ly rep­re­sen­ta­tive group of 1,744 US adults did find that more than half un­der­stood that the reg­u­la­tor ap­proves pre­scrip­tion drugs when the drug of­fers ben­e­fits that out­weigh the risks, al­though 17.5% thought that an FDA-ap­proved drug will cure the con­di­tion for which it’s pre­scribed.

“Fur­ther in­ves­ti­ga­tion in­to pub­lic knowl­edge of FDA’s OTC [over-the-counter] drug and di­etary sup­ple­ment ap­proval over­sight yield­ed ad­di­tion­al ev­i­dence of a lack of un­der­stand­ing re­lat­ed to the ap­proval of such prod­ucts. We found that 69.3% of re­spon­dents thought that FDA ap­proves all over‐the‐ counter drugs. One quar­ter of re­spon­dents (24.9%) be­lieved FDA ap­proves di­etary sup­ple­ments and an­oth­er quar­ter (24.5%) did not know,” the sur­vey’s au­thors found.

In ad­di­tion to the find­ings on the ap­provals, the re­searchers al­so sought to un­der­stand how the pub­lic views FDA’s role in reg­u­lat­ing di­rect-to-con­sumer (DTC) pre­scrip­tion drug ad­ver­tis­ing.

FDA re­searchers found less of an un­der­stand­ing with DTC ads, not­ing that 31% in­cor­rect­ly thought that FDA ap­proves DTC ad­ver­tis­ing, and less than half in­cor­rect­ly thought that risk or ben­e­fit state­ments in ads are FDA‐ap­proved.

Al­though the re­searchers said the sur­vey aligns with pre­vi­ous sur­veys, they al­so said it sug­gests “that some of the mis­con­cep­tions held by con­sumers may have a neg­a­tive im­pact on pub­lic health. For in­stance, we found that 42.9% of con­sumers were not able to ac­cu­rate­ly re­port that FDA‐ap­proved pre­scrip­tion drugs may cause harm. This is con­cern­ing be­cause some ad­verse events re­quire dis­con­tin­u­a­tion or dose mod­i­fi­ca­tion. More­over, ad­verse event re­port­ing is crit­i­cal to phar­ma­covig­i­lance and un­der‐re­port­ing of ad­verse events is a con­sis­tent prob­lem world­wide.”

They al­so ex­plained how there is an op­por­tu­ni­ty to en­hance con­sumers’ un­der­stand­ing of drug ap­provals, FDA’s role and over­sight of pre­scrip­tion drug ad­ver­tise­ments.

As far as po­ten­tial ways to im­prove the pub­lic’s un­der­stand­ing on drug ap­provals, one of the sug­ges­tions is to place ban­ner ads on gen­er­al health ref­er­ence web­sites, like Drugs.com, Web­MD.com and may­oclin­ic.org, with short mes­sages of­fer­ing key facts about the ap­proval process and reg­u­la­tion of ad­ver­tise­ments.

First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. 

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.