Juvéderm Volux XC is said to be the first and only hyaluronic acid (HA) filler to receive US FDA approval for improving jawline definition, and sixth product in the company’s Juvéderm family of fillers

Allergan Aesthetics, a subsidiary of AbbVie, announced that the US FDA has approved its Juvéderm Volux XC for improving jawline definition in adults, aged 21 years and above.

Juvéderm Volux XC is the latest addition to the company’s Juvéderm family of fillers.

It is the sixth product in the portfolio, alongside Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Ultra Plus XC, Juvéderm Ultra XC, and Juvéderm Volbella XC.

The Juvéderm Volux XC is the first and only hyaluronic acid (HA) filler to get FDA approval for improving jawline definition, said Allergan Aesthetics.

Allergan Aesthetics global president and AbbVie senior vice president Carrie Strom said: “The approval of Juvéderm Volux XC represents the largest leap in innovation for our U.S. HA portfolio since the introduction of Juvéderm Voluma XC.

“Juvéderm Volux XC complements our existing product line to provide even more structure, cohesivity and lift capacity to create an improved jawline that appears more defined in real life and on camera.

“Juvéderm Volux XC is what our providers have been asking for to deliver the jaw-dropping results their patients are seeking.”

In the clinical study, participants who received Juvéderm Volux XC experienced an effective improvement of jawline definition at six months.

The participants’ satisfaction through 12 months was determined using the Satisfaction with Lower Face and Jawline module of the FACE-Q questionnaire.

In the study, 81.5% of participants were satisfied with how sculpted (well-defined) their jawline looked at six months, compared to 12.2% at baseline.

The study revealed that 70.5% of participants were satisfied with how smooth their lower face looked, without jowls or folds of fatty skin, compared to 7.7% at baseline.

In addition, 73.1% of participants were satisfied with how nice their lower face looked compared to 9.0% at baseline, at six months.

Tenderness, lumps, pain, swelling, firmness, bruising, redness, itching, and discolouration at the injection sites, include the commonly reported side effects in the clinical study.

Clinical trial investigator Jeremy Green said: “Requests for treatment in the lower facial region transcend age, gender, race, and ethnicity in my practice. As people age, many factors can contribute to how the lower face changes, such as genetics and soft tissue loss.

“This can cause reduced definition around the jawline area that may impact and change the shape of the face and lead to the appearance of jowls. Clinical trial participants reported high satisfaction with the results of their treatment.”

Earlier this year, Allergan Aesthetics received US FDA approval for Juvéderm Volbella XC to improve infraorbital hollows in adults older than 21 years.

British multinational GlaxoSmithKline announced Wednesday that the U.S. Food and Drug Administration gave its Benlysta (belimumab) the greenlight for use against active lupus nephritis in children aged 5 to 17 on standard therapy.

The FDA’s nod extends Benlysta’s indication in the US, making it the first approved treatment for pediatric lupus nephritis. Benlysta was also the first approved targeted therapy for lupus nephritis in adults in 2011.

“This Benlysta approval highlights GSK’s commitment to bring treatment options to children living with lupus nephritis,” Herson Quinones, VP, specialty and pipeline U.S. medical affairs at GSK, said in a statement.

Lupus nephritis is a common complication of systemic lupus erythematosus (SLE), the most common form of lupus. SLE is an autoimmune disease that turns the immune system against the body causing a wide range of symptoms such as painful joints, rashes and organ damage. Lupus nephritis arises when the immune system attacks the kidney, causing inflammation.

Like SLE, lupus nephritis is chronic and incurable. Often, it can lead to end-stage kidney disease, which can only be eased through dialysis or a transplant. Despite medical advancements over the years, the prognosis for lupus nephritis remains bleak.

This is particularly true in young patients, for whom lupus nephritis means high complications, hospitalizations and death rates. The lack of reliable treatment options worsened the situation: children with lupus nephritis are typically treated with corticosteroids or non-selective immunosuppressants, both of which come with many side effects.

Benlysta is a human monoclonal antibody that targets the B-lymphocyte stimulator, a protein crucial for the growth of B cells, helping to counter the abnormal immune response in lupus patients. The drug is also not a steroid and can be combined with other ongoing lupus medications.

The FDA nod for Benlysta was welcome news to the broader lupus community. “This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life,” Stevan W. Gibson, president and CEO, Lupus Foundation of America, said in a statement.

Kenneth M. Farber, president and CEO of the Lupus Research Alliance, agreed: “Our community has much to celebrate with the approval of the first and much-needed treatment for children with lupus nephritis. We are particularly proud to see belimumab approved to help yet another patient population, having funded much of the original research that led to the drug’s development.”

But despite Benlysta’s success, there remain very few targeted treatment options for lupus nephritis and the drug development pipeline is likewise looking dry. Last month, Kezar Life Sciences announced that its candidate zetomipzomib aced its Phase II trial, inducing an overall response rate in 11 out of the 17 enrolled patients.

Also working on cures for lupus nephritis are Equilium, whose first-in-class monoclonal antibody itolizumab is undergoing Phase Ib assessments, and Vera Therapeutics, which is developing atacicept, a recombinant fusion protein that, like Benlysta, lowers B cell survival.

For individuals with weak eyes, spectacles and eyeglasses are unquestionably a blessing. They allow you to walk without tripping over objects, read, and essentially just see what’s in front of you. But they can also be a curse. It is very easy to forget them at home or in the car, they break easily, and Covid, masks have taught us that they fog up real easy, effectively blinding you. But what if you didn’t have to wear those pesky glasses all the time? If you’re living in the United States this is a possibility. The FDA (Food and Drug Administration) has recently approved an eye drop that can replace glasses.

This drug is called Vuity and it claims to improve age-related near-vision. As per an Express.co.uk report, the eye drops need to be applied once every six hours and starts working within 15 minutes of application.

According to the report, the medication is a formulated form of the well-known compound known as pilocarpine, and the researchers have developed it to quickly adapt to the pH of the tear film. 

Utilising the eye’s natural ability to constrict the pupil, the drop enhances near vision while preserving far vision.

The drop is most helpful for people between the ages of 40 and 55, according to the researchers’ analysis of two randomised control trials involving 750 participants.

Moreover, they did not suffer any severe adverse effects; however, a few patients did report minor headaches and eye redness.

AstraZeneca has signed a deal to buy US biotech TeneoTwo in a deal worth up to $1.27 billion that will boost its position therapies for haematological cancers.

The big pharma is paying $100 million upfront for the company, and offering up to $805 million in milestone payments if TeneoTwo’s drug candidates meet development objectives, plus up to $360 million if they hit sales targets.

The deal centres around  TNB-486, a bispecific CD19 and CD3 T-cell engager in phase 1 testing in patients with relapsed and refractory B-cell non-Hodgkin lymphoma (NHL) who have received two or more previous lines of therapy.

T-cell engagers are designed to redirect the immune system’s T-cells to recognise and kill cancer cells and – according to AZ’s head of haematology R&D Anas Younes – TNB-486 given alone or in combination with CD20 drugs like rituximab “could potentially deepen clinical responses and improve patient outcomes.”

If it reaches the market, TNB-486 could be a challenger to current CD3/CD19-targeting therapies like Gilead/Kite’s cell therapy Tecartus (brexucabtagene autoleucel) – used to treat a form of NHL called mantle cell lymphoma as well as acute lymphoblastic leukaemia (ALL) and Amgen’s bispecific antibody Blincyto (blinatumomab) for CD19-positive ALL.

It is also a potential rival to Incyte/MorphoSys’ CD19-targeting antibody Minjuvi(tafasitamab)  – approved last year for another form of NHL called diffuse large B-cell lymphoma (DLBCL) – as well as CD19-directed CAR-T therapies from Gilead, Novartis and Bristol-Myers Squibb.

“We believe this innovative molecule, which was designed to optimise the therapeutic window of T-cell activation, will enable us to explore novel combinations that have the potential to become new standards of care in this setting,” said Younes.

TeneoTwo is one of three companies spun out of Teneobio last year before the company was bought by Amgen for $2.5 billion. Another of those spinouts – TeneoOne– was bought by AbbVie for an undisclosed sum.

The deal is expected to close in the third quarter of this year and is not expected to impact AZ’s financial outlook for 2022, said the pharma group in a statement.

Cancer drugs will be flown from a facility in Portsmouth to a hospital on the Isle of Wight by drone, in the first pilot study of the technology by NHS England.

The trial – announced this morning and said to be the first of its type worldwide – will mean that the lifesaving treatment can be picked up and dropped off to patients on the same day, said NHS chief executive Amanda Pritchard.

The first drone flight is due to take place later today and will go from Portsmouth Hospitals University NHS Trust to St Mary’s Hospital, where staff will collect the chemotherapy drugs before distributing them to hospital teams and patients.

The pilot is focusing on cancer drugs as these can be difficult to transport, as doses have a short shelf life. Using drones will cut the transit time for the medicines from four hours to 30 minutes, and will also require less fuel – an increasingly important consideration as prices rocket at petrol pumps.

At the moment, patients who live on the Isle of Wight often have to travel to the mainland for cancer treatment, so the drones will avoid at least two car journeys and one hovercraft or ferry journey across the Solent per delivery – saving carbon emissions.

Medical drone startup Apian – founded by a team of NHS doctors in training and ex-Google staffers – is supplying the drones for the pilot study.

The company has developed a fleet of unmanned vehicles that include both fixed wing and vertical take off and landing (VTOL) hybrids for long-range flights, and multi-rotor robots that are easier to launch for shorter flight times.

The largest models can carry up to 25kg in weight, and fly for up to 1.5 hours at a maximum speed of 100mph on a single charge. They are able to operate in the same weather conditions as helicopter emergency medical services.

Announcing the initiative on the 74th anniversary of the founding of the NHS, Pritchard said it was further evidence that “the pace of change and improvement across the health service is only accelerating.”

“Delivering chemo by drone is another extraordinary development for cancer patients and shows how the NHS will stop at nothing to ensure people get the treatment they need as promptly as possible, while also cutting costs,” she added.

The Solent pilot will be followed by another pilot in Northumbria, once again focusing on deliver of chemotherapy agents. Apian is also looking at using drones to deliver pathology samples between hospitals and nuclear medicines, amongst other projects.

Bayer has stepped up the digital capabilities of its radiology business with the launch of artificial intelligence-based apps for X-ray, MRI and CT imaging.

The cloud-hosted platform – called Calantic Digital Solutions – has tools to help radiologists detect and quantify disease lesions in medical images and select patients for treatment in order of priority, improving their productivity.

It operates as an online, vendor-neutral marketplace, allowing radiology specialists to select from a growing range of apps that can also automate routine tasks and measurements, improve radiology suites’ workflow, and free up time for other tasks.

Medical imaging is a central plank of disease detection, particularly for cancer, but rising demand combined with a shortage of radiologists – exacerbated by burn-out – is placing pressure on health services around the world.

That pressure can lead to diagnostic errors, with a 2018 study suggesting that there are 40 million errors involving imaging worldwide every year.

“AI has the potential to transform healthcare, and particularly in medical imaging it can turn the growing amounts of data into value-adding insights to support radiologists and their teams in their decision-making,” said Dr Ryan Lee head of radiology at Einstein Healthcare Network in Philadelphia.

“It is crucial to drive innovation in this area and broaden access to digital tools that can help address the rising demand for solutions which improve the speed and accuracy of diagnoses,” he added.

Calantic is organised by body region and procedure, and initially includes apps used in thoracic and neurological diseases, such as pulmonary nodule detection and the detection of potential  intracerebral haemorrhages (ICH) and large vessel occlusions (LVO) – which can be associated with stroke.

Additional disease-specific apps – including from other developers – will be added in future, said Bayer, which is initially launching the platform in the US and several European countries.

Bayer’s radiology division develops and sells injection and fusion systems used in medical imaging procedures, contrast media including Gadovist/Gadavist, Magnevist and Primovist to enhance CT and MRI images, as well as management software under its Radimetrics banner.

The business generated sales of €1.8 billion (approximately $1.9 billion) last year, around 10% of the group’s total healthcare revenues.

The company says that radiology AI is the fastest growing market segment within the overall global radiology market, with a current market value of around €400 million and an annual growth rate of 25%.

“With Calantic Digital Solutions, we are entering the fastest growing segment in the radiology market and taking the next step on our way from a product provider to a solution provider,” said Bayer’s head of radiology Gerd Krueger.

The launch follows the company’s mission “to provide an ecosystem of third-party and Bayer products to deliver state-of-the art disease-oriented solutions for radiologists and their teams.”

According to the draft document prepared by the department of pharmaceuticals, the sector spends an average of 5-6% of its revenues on R&D, which should increase to at least 15%

With an aim of improving India’s position in the global pharmaceuticals market on the innovation index, the Narendra Modi government is preparing to launch a “research-linked incentive scheme”, News18.com has learnt.

Planning India’s shift away from a low-value, high-volume player to a high-value, high-volume player in the global pharma market, the government is in discussions over the proposed scheme with senior industry leaders of top domestic pharmaceutical firms, said sources.

Currently, the Indian pharmaceutical industry is ranked 14th in terms of value and constitutes a 3.4% market share across the globe.

According to the government’s pitch to top domestic pharmaceutical companies, if the industry adopts a business-as-usual approach, the market value would grow to around 108 billion USD by 2030.