Last Ju­ly, the cost-ef­fec­tive­ness drug watch­dog ICER re­leased a pre­lim­i­nary draft re­port that Vivus’ Qsymia was the most cost-ef­fec­tive op­tion for weight loss. That de­ci­sion has now been val­i­dat­ed.

ICER made its fi­nal de­ter­mi­na­tion Wednes­day that Qsymia, the brand name for the ap­petite sup­pres­sant phen­ter­mine com­bined with an­ti­con­vul­sant top­i­ra­mate, was more cost-ef­fec­tive for weight loss than oth­er com­peti­tors such as No­vo Nordisk’s Sax­en­da (li­raglu­tide) and We­govy (semaglu­tide) or Cur­rax Phar­ma­ceu­ti­cals’ Con­trave (bupro­pi­on/nal­trex­one).

At cur­rent prices and with com­mon­ly ac­cept­ed cost-ef­fec­tive­ness bench­marks, re­sults sug­gest that phen­ter­mine/top­i­ra­mate in ad­di­tion to lifestyle mod­i­fi­ca­tion is cost ef­fec­tive com­pared with lifestyle mod­i­fi­ca­tion alone. The cost ef­fec­tive­ness of treat­ment of obe­si­ty with semaglu­tide or li­raglu­tide, in pa­tients with­out di­a­betes mel­li­tus, ex­ceeds com­mon­ly used thresh­olds.

The watch­dog men­tioned that the health-ben­e­fit price bench­mark for the more fa­mous semaglu­tide, which al­so was more ef­fec­tive than the oth­er No­vo Nordisk drug and Con­trave, is $7,500 to $9,800 per year. But at its cur­rent price point, it would re­quire the drug be dis­count­ed some­where be­tween 44-57% of its whole­sale price.

ICER re­view­ers al­so added that if Qsymia wasn’t per­form­ing well in cer­tain pa­tients, Con­trave may be the next best cost-ef­fec­tive op­tion. The re­view­ers not­ed in their re­port that there were a few lim­i­ta­tions to analy­sis, in­clud­ing the full im­pact of the drugs in pa­tients with chron­ic kid­ney dis­eases or con­di­tions where weight loss may be ben­e­fi­cial.

Vivus nabbed ap­proval for Qsymia in adults in 2012, fol­lowed by a tu­mul­tuous his­to­ry that end­ed up with Vivus fil­ing for bank­rupt­cy. Years lat­er, the FDA ex­pand­ed Qsymia’s weight loss in­di­ca­tion from just adults to use in ado­les­cents. How­ev­er, the reg­u­la­to­ry agency added the con­di­tion that the drug is giv­en on top of both a re­duced-calo­rie di­et and in­creased phys­i­cal ac­tiv­i­ty.

Vivus CEO John Amos told End­points News last month af­ter ICER’s draft re­port that so far, Qsymia is av­er­ag­ing around $40 mil­lion to $42 mil­lion in an­nu­al sales and in the range of 400,000 scripts every year. And in ap­provals, Qsymia has been ap­proved out­side the US in South Ko­rea, the five Nordic coun­tries and Poland — with more ap­provals pend­ing in oth­er Eu­ro­pean coun­tries such as the UK.

ICER’s de­ci­sion comes the same week Cur­rax launched a new ad cam­paign for Con­trave, fo­cused on the drug as a choice for emo­tion­al eat­ing con­nect­ed to obe­si­ty and over­weight con­di­tions.

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago — in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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